Benjamin F Calvo | Roswell Park Cancer Institute (original) (raw)

Papers by Benjamin F Calvo

Research paper thumbnail of NF-κB is activated by radiotherapy and is prognostic for overall survival in patients with rectal cancer treated with preoperative fluorouracil-based chemoradiation

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2011

Research paper thumbnail of Outcomes of surgical resection and intraoperative electron radiotherapy for patients with para-aortic recurrences of gastrointestinal and gynecologic malignancies

Radiation Oncology, Jun 2, 2023

Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often tr... more Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often treated with resection, but recurrence is common. We report toxicity and oncologic outcomes for patients with PALN metastases from gastrointestinal and gynecologic malignancies treated with resection and intraoperative electron radiotherapy (IORT). We retrospectively identified patients with recurrent PALN metastases who underwent resection with IORT. All patients were included in the local recurrence (LR) and toxicity analyses. Only patients with primary colorectal tumors were included in the survival analysis. There were 26 patients with a median follow up of 10.4 months. The rate of para-aortic local control (LC) was 77% (20/26 patients) and the rate of any cancer recurrence was 58% (15/26 patients). Median time from surgery and IORT to any recurrence was 7 months. The LR rate for those with positive/close margins was 58% (7/12 patients) versus 7% (1/14 patients) for those with negative margins (p = 0.009). 15% (4/26 patients) developed surgical wound and/or infectious complications, 8% (2/26 patients) developed lower extremity edema, 8% (2/26 patients) experienced diarrhea, and 19% (5/26 patients) developed an acute kidney injury. There were no reported nerve injuries, bowel perforations, or bowel obstructions. For patients with primary colorectal tumors (n = 19), the median survival (OS) was 23 months. Conclusions We report favorable LC and acceptable toxicity for patients receiving surgical resection and IORT for a population that has historically poor outcomes. Our data show disease control rates similar to literature comparisons for patients with strong risk factors for LR, such as positive/close margins.

Research paper thumbnail of Activation of a Novel Calcium-dependent Protein-tyrosine Kinase: CORRELATION WITH c-Jun N-TERMINAL KINASE BUT NOT MITOGEN-ACTIVATED PROTEIN KINASE ACTIVATION

Carolina Digital Repository (University of North Carolina at Chapel Hill), 1996

Research paper thumbnail of Expression and regulation of nonsteroidal anti-inflammatory drug–activated gene (NAG-1) in human and mouse tissue

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2002

Research paper thumbnail of A Phase I Study of Bortezomib in Combination With Standard 5-Fluorouracil and External-Beam Radiation Therapy for the Treatment of Locally Advanced or Metastatic Rectal Cancer

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2010

Research paper thumbnail of Extracapsular Extension of the Sentinel Lymph Node Metastasis: A Predictor of Nonsentinel Node Tumor Burden

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2003

Research paper thumbnail of Axillary lymph node count is lower after neoadjuvant chemotherapy

American Journal of Surgery, Jun 1, 2006

Background: Retrieval of fewer than 10 lymph nodes at axillary dissection (ALND) for breast cance... more Background: Retrieval of fewer than 10 lymph nodes at axillary dissection (ALND) for breast cancer can represent anatomic variation or inadequate dissection. We postulated that despite aggressive ALND, a lower lymph node count is more frequent after neoadjuvant chemotherapy. Methods: Patients who received neoadjuvant chemotherapy followed by ALND were compared with patients who received surgery first. All patients received a level I and II ALND at a single institution by one of the breast surgeons. The number of nodes retrieved at ALND was dichotomized into categories (Ͻ10 and Ն10), and compared using Fisher exact test. Results: A total of 143 neoadjuvant and 170 surgery-first patients were studied. Patients treated with neoadjuvant chemotherapy were significantly more likely to have fewer than 10 lymph nodes retrieved at ALND than were the surgery-first patients (19/143 or 13% vs. 6/170 or 4%, P ϭ .003). Conclusions: A low lymph node count is more common in patients after treatment with neoadjuvant chemotherapy and should not be assumed to represent an incomplete ALND.

Research paper thumbnail of Size of Residual Lymph Node Metastasis After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients Is Prognostic

Annals of Surgical Oncology, Mar 9, 2006

The prognostic significance of micrometastasis after neoadjuvant chemotherapy for locally advance... more The prognostic significance of micrometastasis after neoadjuvant chemotherapy for locally advanced breast cancer is unknown. We examined the residual lymph node metastasis size in patients after treatment with neoadjuvant chemotherapy to determine the relevance of metastasis size on outcome. Stage II/III breast cancer patients treated with neoadjuvant chemotherapy at our institution from 1991 to 2002 were included. We examined the relationship of postneoadjuvant chemotherapy lymph node metastasis size and number with distant disease-free survival (DDFS) and overall survival (OS). In 122 patients with a median follow-up of 5.4 years, we found not only that patients with an increasing number of residual positive nodes had progressively worse DDFS and OS (P < .0001 for both) compared with patients with negative nodes, but also that the size of the largest lymph node metastasis was associated with worse DDFS and OS (P < .0001 for both) in both univariate and multivariate analysis. Compared with negative nodes, even lymph node micrometastasis (<2 mm) was associated with worsened DDFS and OS (adjusted P = .02 and P = .005, respectively). Residual micrometastatic disease in the axillary lymph nodes after neoadjuvant chemotherapy is predictive of worse prognosis than negative nodes. In this study, the lymph node metastasis size and the number of involved lymph nodes were independent powerful predictors of DDFS and OS.

Research paper thumbnail of Long-Term Outcome of Neoadjuvant Therapy for Locally Advanced Breast Carcinoma

Annals of Surgery, Sep 1, 2002

Research paper thumbnail of Retrospective Cohort of Patients Treated for Paraaortic and Paracaval Recurrence With Intraoperative Radiation Therapy

International Journal of Radiation Oncology Biology Physics, Nov 1, 2021

PURPOSE/OBJECTIVE(S) Intraoperative electron radiation therapy (IOERT) may improve local control ... more PURPOSE/OBJECTIVE(S) Intraoperative electron radiation therapy (IOERT) may improve local control when combined with resection +/- external beam RT when there is concern regarding surgical margins (R1 or R2 disease). IOERT allows for delivery of additional radiation while minimizing dose to normal tissue as they can be physically removed from the RT field. While there is a strong body of literature on the use of IOERT in the pelvis, much less is known for treatment of paraaortic and paracaval tumors, where R0 surgical resection is difficult because of vascular or soft tissue involvement. We examined outcomes after surgery and IOERT for treatment of paraaortic and paracaval recurrences. MATERIALS/METHODS We conducted a retrospective analysis of patients treated with IOERT to the paraaortic or paracaval region for nodal cancer recurrence between 2008 and 2020 at a single academic institution. Patients selected for IOERT in a multidisciplinary setting had isolated paracaval or paraaortic recurrence, and were deemed good candidates to undergo aggressive surgery with IOERT with curative intent. Overall survival (OS) and progression free survival (PFS) were calculated using Kaplan-Meier statistics with R statistical computing software. RESULTS Twenty-six patients received IOERT to the paraaortic or paracaval region. Median follow up was 6.5 months (range 0-96). Primary cancer types included 19 colorectal, 2 appendiceal, 2 endometrial, 2 cervical, and 1 ovarian. Twelve patients (46%) had pre-operative EBRT to the paraaortic/paracaval area and 7 additional patients had EBRT to another site prior to IOERT (73% total prior RT). Two patients had multi-site IOERT. IOERT was delivered with 6-12 MeV electrons with 10-20 Gy per treatment (Table 1). One patient was treated to 2 sites and another to 3 sites. Of the 15 patients with known post-IOERT recurrences, 5 had isolated in-field local recurrences (LR), 7 had distant recurrences, and 3 had both local and distant recurrences. Two of the eight LR were in patients treated to multiple sites with IOERT with the LR in the pelvis (not included in paraaortic recurrence). Local control of paraaortic region at 1 year was improved when surgery had negative margins (83%) versus close margins (25%) or positive margins (0%) (Chi-squared P = 0.01). Crude local control in the paraaortic region with IOERT was 77%; it was 93% with negative margins and 58% with close or positive margins. The median OS of the entire cohort was 9 months, with 1 year OS of 64.6% (std error 11.0%), median PFS 4 months, and 1-year PFS of 32.6% (std error 11.6%). Of the 17 patients with colorectal cancer, 1 year OS was 70.2% (std error 12.8%) and 1-year PFS was 17.6% (std error 11.1%). CONCLUSION IOERT to the paraaortic or paracaval region for cancer recurrence may contribute to local control for patients at high risk of local recurrence after surgery alone, although survival outcomes remain poor due to distant failures.

Research paper thumbnail of Colorectal adenocarcinomas have increased EGFR ligand expression

Journal of The American College of Surgeons, Sep 1, 2006

Research paper thumbnail of Tumor ecosystem differences in 75 pancreatic ductal adenocarcinoma patients after neoadjuvant chemotherapy vs no neoadjuvant chemotherapy

Research paper thumbnail of A phase IB/II study of neoadjuvant chemoradiotherapy with CRLX101 and capecitabine for locally advanced rectal cancer

Journal of Clinical Oncology, 2014

e15144 Background: There is strong interest in the development of novel agents to further improve... more e15144 Background: There is strong interest in the development of novel agents to further improve the therapeutic ratio of neoadjuvant chemoradiotherapy for rectal cancer. CRLX101 is an investigational nanoparticle-drug conjugate with a camptothecin payload. The purpose of this Phase Ib/II study is to assess toxicity and to evaluate whether the addition of CRLX101 to chemoradiotherapy can improve pathologic complete response (pCR) for rectal cancer. Methods: This is a single-arm multicenter Phase Ib/II study examining the addition of CRLX101 to a standard capecitabine-based chemoradiotherapy regimen. Phase Ib employs a 3+3 dose escalation design with starting dose of 12 mg/m2 every other week (QOW). Dose level +1 was 15 mg/m2 (MTD for CRLX101 single agent QOW). Upon reaching MTD for QOW dosing, protocol was modified to evaluate QW CRLX101 dosing starting at 12 mg/m2 and 15 mg/m2as +1 level. Secondary endpoints included pCR and clinical outcome. Results: A total of 32 patients were enrolled on the trial. 26/32 had T3-4, 9/32 had N2 and 16/32 had N1 disease. For QOW dosing, 9 patients completed treatment without DLT and MTD was identified as 15 mg/m2 QOW. 14 patients were treated on the Phase II portion of the study at 15 mg/m2 QOW prior to the initiation of weekly dosing Phase Ib cohorts. For QW dosing, 0/3 patients experienced DLT at 12 mg/m2 and 1/6 patients experienced DLT at 15 mg/m2. The DLT was skin desquamation requiring treatment delay. QW MTD was identified as 15 mg/m2. Toxicities (all grade 3 except lymphopenia) that could possibly be attributed to CRLX101 are in Table 1. Full clinical and pathologic staging were available for 29/32 patients. Mean neoadjuvant rectal (NAR) score was 19 with standard deviation of 15. At the weekly MTD, 3/6 patients had pCR. Conclusions: CRLX101 weekly at 15 mg/m2+ standard capecitabine-based chemoradiotherapy appears to be well tolerated, with promising pCR rates that warrants further evaluation. A larger PhII trial should be considered with this regimen. Clinical trial information: NCT02010567. [Table: see text]

Research paper thumbnail of Phase 1b/2 Study of Neoadjuvant Chemoradiation Therapy With CRLX101 and Capecitabine for Locally Advanced Rectal Cancer

International Journal of Radiation Oncology*Biology*Physics, 2017

Research paper thumbnail of Locoregional control in locally advanced breast cancer using neoadjuvant chemotherapy followed by breast conservation

Journal of Clinical Oncology, 2008

539 Background: Neoadjuvant chemotherapy is commonly employed in the treatment of locally advance... more 539 Background: Neoadjuvant chemotherapy is commonly employed in the treatment of locally advanced breast cancer. However, the difference in local-regional recurrence (LRR) rates between those undergoing BCT and those with mastectomy is not well defined. The purpose of this study was to examine the incidence of LRR in these two groups after neoadjuvant chemotherapy at a single institution. Methods: Under IRB approval, a prospective database was utilized to identify all patients with locally advanced Stage II and III breast cancer undergoing neoadjuvant chemotherapy from 1991 to 2005. Patients presenting with stage IV disease or T4d primary breast cancer were excluded from this analysis. LRR was compared between those undergoing BCT and mastectomy by log-rank test and Cox regression analysis was utilized to evaluate individual variables associated with LRR. Results: 236 patients were included, 94 (40%) underwent BCT and 142 (60%) mastectomy. 93/94 (99%) of the BCT and 115/142 (81%) of the mastectomy patien...

Research paper thumbnail of Oncologic outcomes following radical resection with intraoperative electron radiation therapy in patients with recurrent colorectal cancer

Journal of Clinical Oncology, 2011

508 Background: Of the 40,000 rectal cancer patients treated annually, up to 15% will experience ... more 508 Background: Of the 40,000 rectal cancer patients treated annually, up to 15% will experience a local recurrence (LR). Resection only series for LR report 30–60% positive margin rates. For this reason our institution utilizes intra-operative electron radiation therapy (IOERT) in patients undergoing resection of locally advanced rectal cancer recurrences (LA-RRC). The purpose of this study was to evaluate the oncologic outcomes of patients treated for a LA-RRC with resection and IOERT Methods: Under IRB approval a prospective database of patients with LA-RRC undergoing resection and IOERT from April 2001 to January 2010 was analyzed. Demographic, clinical, and pathologic variables were collected. The Kaplan-Meier method estimated 5-year overall survival (OS) and Fisher's Exact test's explored associations for developing a LR. Results: Fifty patients (32 male, mean age 58 ± 11) underwent resection and IOERT (median dose 1500 cGy, energy 9 MeV). Primary procedures included p...

Research paper thumbnail of 2039 Phase IB/II study of neoadjuvant chemoradiotherapy with CRLX101 and capecitabine for locally advanced rectal cancer

European Journal of Cancer, 2015

Research paper thumbnail of Long-Term Outcome of Neoadjuvant Therapy for Locally Advanced Breast Carcinoma: Effective Clinical Downstaging Allows Breast Preservation and Predicts Outstanding Local Control and Survival

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2002

Research paper thumbnail of Outcomes of surgical resection and intraoperative electron radiotherapy for patients with para-aortic recurrences of gastrointestinal and gynecologic malignancies

Radiation Oncology

Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often tr... more Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often treated with resection, but recurrence is common. We report toxicity and oncologic outcomes for patients with PALN metastases from gastrointestinal and gynecologic malignancies treated with resection and intraoperative electron radiotherapy (IORT). Methods We retrospectively identified patients with recurrent PALN metastases who underwent resection with IORT. All patients were included in the local recurrence (LR) and toxicity analyses. Only patients with primary colorectal tumors were included in the survival analysis. Results There were 26 patients with a median follow up of 10.4 months. The rate of para-aortic local control (LC) was 77% (20/26 patients) and the rate of any cancer recurrence was 58% (15/26 patients). Median time from surgery and IORT to any recurrence was 7 months. The LR rate for those with positive/close margins was 58% (7/12 patients) versus 7% (1/14 patients) for tho...

Research paper thumbnail of Hiperplasia benigna de próstata

Aula De La Farmacia Revista Profesional De Formacion Continuada, 2010

La hiperplasia benigna de prostata es una de las patologias mas frecuentes en perros. Aunque su e... more La hiperplasia benigna de prostata es una de las patologias mas frecuentes en perros. Aunque su etiopatogenia no se conoce bien, existen metodos eficaces para su diagnostico y diferentes alternativas terapeuticas.

Research paper thumbnail of NF-κB is activated by radiotherapy and is prognostic for overall survival in patients with rectal cancer treated with preoperative fluorouracil-based chemoradiation

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2011

Research paper thumbnail of Outcomes of surgical resection and intraoperative electron radiotherapy for patients with para-aortic recurrences of gastrointestinal and gynecologic malignancies

Radiation Oncology, Jun 2, 2023

Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often tr... more Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often treated with resection, but recurrence is common. We report toxicity and oncologic outcomes for patients with PALN metastases from gastrointestinal and gynecologic malignancies treated with resection and intraoperative electron radiotherapy (IORT). We retrospectively identified patients with recurrent PALN metastases who underwent resection with IORT. All patients were included in the local recurrence (LR) and toxicity analyses. Only patients with primary colorectal tumors were included in the survival analysis. There were 26 patients with a median follow up of 10.4 months. The rate of para-aortic local control (LC) was 77% (20/26 patients) and the rate of any cancer recurrence was 58% (15/26 patients). Median time from surgery and IORT to any recurrence was 7 months. The LR rate for those with positive/close margins was 58% (7/12 patients) versus 7% (1/14 patients) for those with negative margins (p = 0.009). 15% (4/26 patients) developed surgical wound and/or infectious complications, 8% (2/26 patients) developed lower extremity edema, 8% (2/26 patients) experienced diarrhea, and 19% (5/26 patients) developed an acute kidney injury. There were no reported nerve injuries, bowel perforations, or bowel obstructions. For patients with primary colorectal tumors (n = 19), the median survival (OS) was 23 months. Conclusions We report favorable LC and acceptable toxicity for patients receiving surgical resection and IORT for a population that has historically poor outcomes. Our data show disease control rates similar to literature comparisons for patients with strong risk factors for LR, such as positive/close margins.

Research paper thumbnail of Activation of a Novel Calcium-dependent Protein-tyrosine Kinase: CORRELATION WITH c-Jun N-TERMINAL KINASE BUT NOT MITOGEN-ACTIVATED PROTEIN KINASE ACTIVATION

Carolina Digital Repository (University of North Carolina at Chapel Hill), 1996

Research paper thumbnail of Expression and regulation of nonsteroidal anti-inflammatory drug–activated gene (NAG-1) in human and mouse tissue

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2002

Research paper thumbnail of A Phase I Study of Bortezomib in Combination With Standard 5-Fluorouracil and External-Beam Radiation Therapy for the Treatment of Locally Advanced or Metastatic Rectal Cancer

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2010

Research paper thumbnail of Extracapsular Extension of the Sentinel Lymph Node Metastasis: A Predictor of Nonsentinel Node Tumor Burden

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2003

Research paper thumbnail of Axillary lymph node count is lower after neoadjuvant chemotherapy

American Journal of Surgery, Jun 1, 2006

Background: Retrieval of fewer than 10 lymph nodes at axillary dissection (ALND) for breast cance... more Background: Retrieval of fewer than 10 lymph nodes at axillary dissection (ALND) for breast cancer can represent anatomic variation or inadequate dissection. We postulated that despite aggressive ALND, a lower lymph node count is more frequent after neoadjuvant chemotherapy. Methods: Patients who received neoadjuvant chemotherapy followed by ALND were compared with patients who received surgery first. All patients received a level I and II ALND at a single institution by one of the breast surgeons. The number of nodes retrieved at ALND was dichotomized into categories (Ͻ10 and Ն10), and compared using Fisher exact test. Results: A total of 143 neoadjuvant and 170 surgery-first patients were studied. Patients treated with neoadjuvant chemotherapy were significantly more likely to have fewer than 10 lymph nodes retrieved at ALND than were the surgery-first patients (19/143 or 13% vs. 6/170 or 4%, P ϭ .003). Conclusions: A low lymph node count is more common in patients after treatment with neoadjuvant chemotherapy and should not be assumed to represent an incomplete ALND.

Research paper thumbnail of Size of Residual Lymph Node Metastasis After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients Is Prognostic

Annals of Surgical Oncology, Mar 9, 2006

The prognostic significance of micrometastasis after neoadjuvant chemotherapy for locally advance... more The prognostic significance of micrometastasis after neoadjuvant chemotherapy for locally advanced breast cancer is unknown. We examined the residual lymph node metastasis size in patients after treatment with neoadjuvant chemotherapy to determine the relevance of metastasis size on outcome. Stage II/III breast cancer patients treated with neoadjuvant chemotherapy at our institution from 1991 to 2002 were included. We examined the relationship of postneoadjuvant chemotherapy lymph node metastasis size and number with distant disease-free survival (DDFS) and overall survival (OS). In 122 patients with a median follow-up of 5.4 years, we found not only that patients with an increasing number of residual positive nodes had progressively worse DDFS and OS (P < .0001 for both) compared with patients with negative nodes, but also that the size of the largest lymph node metastasis was associated with worse DDFS and OS (P < .0001 for both) in both univariate and multivariate analysis. Compared with negative nodes, even lymph node micrometastasis (<2 mm) was associated with worsened DDFS and OS (adjusted P = .02 and P = .005, respectively). Residual micrometastatic disease in the axillary lymph nodes after neoadjuvant chemotherapy is predictive of worse prognosis than negative nodes. In this study, the lymph node metastasis size and the number of involved lymph nodes were independent powerful predictors of DDFS and OS.

Research paper thumbnail of Long-Term Outcome of Neoadjuvant Therapy for Locally Advanced Breast Carcinoma

Annals of Surgery, Sep 1, 2002

Research paper thumbnail of Retrospective Cohort of Patients Treated for Paraaortic and Paracaval Recurrence With Intraoperative Radiation Therapy

International Journal of Radiation Oncology Biology Physics, Nov 1, 2021

PURPOSE/OBJECTIVE(S) Intraoperative electron radiation therapy (IOERT) may improve local control ... more PURPOSE/OBJECTIVE(S) Intraoperative electron radiation therapy (IOERT) may improve local control when combined with resection +/- external beam RT when there is concern regarding surgical margins (R1 or R2 disease). IOERT allows for delivery of additional radiation while minimizing dose to normal tissue as they can be physically removed from the RT field. While there is a strong body of literature on the use of IOERT in the pelvis, much less is known for treatment of paraaortic and paracaval tumors, where R0 surgical resection is difficult because of vascular or soft tissue involvement. We examined outcomes after surgery and IOERT for treatment of paraaortic and paracaval recurrences. MATERIALS/METHODS We conducted a retrospective analysis of patients treated with IOERT to the paraaortic or paracaval region for nodal cancer recurrence between 2008 and 2020 at a single academic institution. Patients selected for IOERT in a multidisciplinary setting had isolated paracaval or paraaortic recurrence, and were deemed good candidates to undergo aggressive surgery with IOERT with curative intent. Overall survival (OS) and progression free survival (PFS) were calculated using Kaplan-Meier statistics with R statistical computing software. RESULTS Twenty-six patients received IOERT to the paraaortic or paracaval region. Median follow up was 6.5 months (range 0-96). Primary cancer types included 19 colorectal, 2 appendiceal, 2 endometrial, 2 cervical, and 1 ovarian. Twelve patients (46%) had pre-operative EBRT to the paraaortic/paracaval area and 7 additional patients had EBRT to another site prior to IOERT (73% total prior RT). Two patients had multi-site IOERT. IOERT was delivered with 6-12 MeV electrons with 10-20 Gy per treatment (Table 1). One patient was treated to 2 sites and another to 3 sites. Of the 15 patients with known post-IOERT recurrences, 5 had isolated in-field local recurrences (LR), 7 had distant recurrences, and 3 had both local and distant recurrences. Two of the eight LR were in patients treated to multiple sites with IOERT with the LR in the pelvis (not included in paraaortic recurrence). Local control of paraaortic region at 1 year was improved when surgery had negative margins (83%) versus close margins (25%) or positive margins (0%) (Chi-squared P = 0.01). Crude local control in the paraaortic region with IOERT was 77%; it was 93% with negative margins and 58% with close or positive margins. The median OS of the entire cohort was 9 months, with 1 year OS of 64.6% (std error 11.0%), median PFS 4 months, and 1-year PFS of 32.6% (std error 11.6%). Of the 17 patients with colorectal cancer, 1 year OS was 70.2% (std error 12.8%) and 1-year PFS was 17.6% (std error 11.1%). CONCLUSION IOERT to the paraaortic or paracaval region for cancer recurrence may contribute to local control for patients at high risk of local recurrence after surgery alone, although survival outcomes remain poor due to distant failures.

Research paper thumbnail of Colorectal adenocarcinomas have increased EGFR ligand expression

Journal of The American College of Surgeons, Sep 1, 2006

Research paper thumbnail of Tumor ecosystem differences in 75 pancreatic ductal adenocarcinoma patients after neoadjuvant chemotherapy vs no neoadjuvant chemotherapy

Research paper thumbnail of A phase IB/II study of neoadjuvant chemoradiotherapy with CRLX101 and capecitabine for locally advanced rectal cancer

Journal of Clinical Oncology, 2014

e15144 Background: There is strong interest in the development of novel agents to further improve... more e15144 Background: There is strong interest in the development of novel agents to further improve the therapeutic ratio of neoadjuvant chemoradiotherapy for rectal cancer. CRLX101 is an investigational nanoparticle-drug conjugate with a camptothecin payload. The purpose of this Phase Ib/II study is to assess toxicity and to evaluate whether the addition of CRLX101 to chemoradiotherapy can improve pathologic complete response (pCR) for rectal cancer. Methods: This is a single-arm multicenter Phase Ib/II study examining the addition of CRLX101 to a standard capecitabine-based chemoradiotherapy regimen. Phase Ib employs a 3+3 dose escalation design with starting dose of 12 mg/m2 every other week (QOW). Dose level +1 was 15 mg/m2 (MTD for CRLX101 single agent QOW). Upon reaching MTD for QOW dosing, protocol was modified to evaluate QW CRLX101 dosing starting at 12 mg/m2 and 15 mg/m2as +1 level. Secondary endpoints included pCR and clinical outcome. Results: A total of 32 patients were enrolled on the trial. 26/32 had T3-4, 9/32 had N2 and 16/32 had N1 disease. For QOW dosing, 9 patients completed treatment without DLT and MTD was identified as 15 mg/m2 QOW. 14 patients were treated on the Phase II portion of the study at 15 mg/m2 QOW prior to the initiation of weekly dosing Phase Ib cohorts. For QW dosing, 0/3 patients experienced DLT at 12 mg/m2 and 1/6 patients experienced DLT at 15 mg/m2. The DLT was skin desquamation requiring treatment delay. QW MTD was identified as 15 mg/m2. Toxicities (all grade 3 except lymphopenia) that could possibly be attributed to CRLX101 are in Table 1. Full clinical and pathologic staging were available for 29/32 patients. Mean neoadjuvant rectal (NAR) score was 19 with standard deviation of 15. At the weekly MTD, 3/6 patients had pCR. Conclusions: CRLX101 weekly at 15 mg/m2+ standard capecitabine-based chemoradiotherapy appears to be well tolerated, with promising pCR rates that warrants further evaluation. A larger PhII trial should be considered with this regimen. Clinical trial information: NCT02010567. [Table: see text]

Research paper thumbnail of Phase 1b/2 Study of Neoadjuvant Chemoradiation Therapy With CRLX101 and Capecitabine for Locally Advanced Rectal Cancer

International Journal of Radiation Oncology*Biology*Physics, 2017

Research paper thumbnail of Locoregional control in locally advanced breast cancer using neoadjuvant chemotherapy followed by breast conservation

Journal of Clinical Oncology, 2008

539 Background: Neoadjuvant chemotherapy is commonly employed in the treatment of locally advance... more 539 Background: Neoadjuvant chemotherapy is commonly employed in the treatment of locally advanced breast cancer. However, the difference in local-regional recurrence (LRR) rates between those undergoing BCT and those with mastectomy is not well defined. The purpose of this study was to examine the incidence of LRR in these two groups after neoadjuvant chemotherapy at a single institution. Methods: Under IRB approval, a prospective database was utilized to identify all patients with locally advanced Stage II and III breast cancer undergoing neoadjuvant chemotherapy from 1991 to 2005. Patients presenting with stage IV disease or T4d primary breast cancer were excluded from this analysis. LRR was compared between those undergoing BCT and mastectomy by log-rank test and Cox regression analysis was utilized to evaluate individual variables associated with LRR. Results: 236 patients were included, 94 (40%) underwent BCT and 142 (60%) mastectomy. 93/94 (99%) of the BCT and 115/142 (81%) of the mastectomy patien...

Research paper thumbnail of Oncologic outcomes following radical resection with intraoperative electron radiation therapy in patients with recurrent colorectal cancer

Journal of Clinical Oncology, 2011

508 Background: Of the 40,000 rectal cancer patients treated annually, up to 15% will experience ... more 508 Background: Of the 40,000 rectal cancer patients treated annually, up to 15% will experience a local recurrence (LR). Resection only series for LR report 30–60% positive margin rates. For this reason our institution utilizes intra-operative electron radiation therapy (IOERT) in patients undergoing resection of locally advanced rectal cancer recurrences (LA-RRC). The purpose of this study was to evaluate the oncologic outcomes of patients treated for a LA-RRC with resection and IOERT Methods: Under IRB approval a prospective database of patients with LA-RRC undergoing resection and IOERT from April 2001 to January 2010 was analyzed. Demographic, clinical, and pathologic variables were collected. The Kaplan-Meier method estimated 5-year overall survival (OS) and Fisher's Exact test's explored associations for developing a LR. Results: Fifty patients (32 male, mean age 58 ± 11) underwent resection and IOERT (median dose 1500 cGy, energy 9 MeV). Primary procedures included p...

Research paper thumbnail of 2039 Phase IB/II study of neoadjuvant chemoradiotherapy with CRLX101 and capecitabine for locally advanced rectal cancer

European Journal of Cancer, 2015

Research paper thumbnail of Long-Term Outcome of Neoadjuvant Therapy for Locally Advanced Breast Carcinoma: Effective Clinical Downstaging Allows Breast Preservation and Predicts Outstanding Local Control and Survival

Carolina Digital Repository (University of North Carolina at Chapel Hill), 2002

Research paper thumbnail of Outcomes of surgical resection and intraoperative electron radiotherapy for patients with para-aortic recurrences of gastrointestinal and gynecologic malignancies

Radiation Oncology

Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often tr... more Background Para-aortic lymph node (PALN) metastases from primary pelvic malignancies are often treated with resection, but recurrence is common. We report toxicity and oncologic outcomes for patients with PALN metastases from gastrointestinal and gynecologic malignancies treated with resection and intraoperative electron radiotherapy (IORT). Methods We retrospectively identified patients with recurrent PALN metastases who underwent resection with IORT. All patients were included in the local recurrence (LR) and toxicity analyses. Only patients with primary colorectal tumors were included in the survival analysis. Results There were 26 patients with a median follow up of 10.4 months. The rate of para-aortic local control (LC) was 77% (20/26 patients) and the rate of any cancer recurrence was 58% (15/26 patients). Median time from surgery and IORT to any recurrence was 7 months. The LR rate for those with positive/close margins was 58% (7/12 patients) versus 7% (1/14 patients) for tho...

Research paper thumbnail of Hiperplasia benigna de próstata

Aula De La Farmacia Revista Profesional De Formacion Continuada, 2010

La hiperplasia benigna de prostata es una de las patologias mas frecuentes en perros. Aunque su e... more La hiperplasia benigna de prostata es una de las patologias mas frecuentes en perros. Aunque su etiopatogenia no se conoce bien, existen metodos eficaces para su diagnostico y diferentes alternativas terapeuticas.