PCN5 Microwave Ablation Compared with Hepatic Resection for the Treatment of Hepatocellular Carcinoma and Liver Metastases: A Systematic-Review and Meta-Analysis (original) (raw)
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Clinical Lymphoma and Myeloma, 2009
Several studies have demonstrated that the addition of rituximab to cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP; R-CHOP) chemotherapy administered as a 21-day cycle (CHOP-21) significantly improved survival outcomes for patients with diffuse large B-cell lymphoma (DLBCL). 1-3 Pfreundscheh et al showed that the CHOP regimen administered every 2 weeks (CHOP-14) improved 5-year overall survival (OS) by 13% compared to standard CHOP-21 chemotherapy. 4 Although the RICOVER-60 trial demonstrated that the addition of rituximab to CHOP-14 provided a significant survival advantage compared with CHOP-14 alone, 5 no prospective trial data had directly compared the R-CHOP-14 and R-CHOP-21 regimens in patients with DLBCL. This randomized phase III study was designed to evaluate the efficacy and toxicity of R-CHOP-14 as compared with standard R-CHOP-21 in newly diagnosed patients with DLBCL, the results of which were recently reported by Cunningham et al at the 2009 meeting of the American Society of Clinical Oncology (ASCO) and are summarized herein. 6 In this trial, newly diagnosed patients with all stages of CD20 + DLBCL were randomized to receive either 8 cycles of standard R-CHOP-21 or 6 cycles of R-CHOP-14 plus 2 cycles of rituximab. While all patients on the R-CHOP-14 arm received lenogras-tim on days 4 through 12, patients on the R-CHOP-21 arm received granulocyte colony-stimulating factor (G-CSF) only when dictated by neutropenia, neutropenic infection, and treatment delays. Stratification was based on age (≤ 60 years vs. > 60 years), World Health Organization performance status (PS; 0-1 vs. 2), lactate dehydrogenase (LDH) level (normal vs. elevated), and treatment center. The primary endpoint of the study was OS, while secondary endpoints were failure-free survival (FFS), toxicity up to 30 days post therapy, and response. Between March 2005 and November 2008, a total of 1080 patients were enrolled in the study. Of these, 540 patients were randomized to each treatment arm. The treatment arms were well balanced in terms of International Prognostic Index (IPI) score, stage III/IV disease, B symptoms, and presence of bulky disease. The median age was 61 years in both arms, with 44% and 49% in the R-CHOP-21 arm presenting with B symptoms and bulky disease and 47% and 52%, respectively, in the R-CHOP-14 arm. About 62% in each treatment arm presented with stage III/IV disease, and more than half of the patients showed an IPI score of 2-3. Eighty-two percent of patients in the R-CHOP-21 arm received 7-8 cycles of therapy compared with 91% on the R-CHOP-14 arm, which might partly be attributable to the last 2 cycles in the R-CHOP-14 arm being single-agent rituximab. More patients on the R-CHOP-21 arm discontinued therapy due to lack of response/progressive disease (PD) or death compared with those on the R-CHOP-14 arm (28 patients vs. 12 patients). Nonhematologic toxicities were similar in both treatment arms. However, comparing the treatment arms in
Journal of Hepatocellular Carcinoma, 2021
Background: Several systemic agents have been approved for use in advanced hepatocellular carcinoma (aHCC). However, it is unclear which treatment is superior in either the firstor second-line settings due to the paucity of head-to-head comparative trials. Therefore, we have conducted a systematic review and network meta-analysis for the indirect comparison of the systemic agents in the first line and second line settings. Methods: Randomized clinical trials evaluating systemic agents in first and second line settings in aHCC from inception to April 2020 were identified by searching PubMed, EMBASE, and Cochrane Databases and the annual ASCO and ESMO conferences from 2017 to 2020. Studies in English reporting clinical outcomes including overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) were included. The primary outcomes of interest were pooled hazard ratios (HR) of OS and pooled odds ratios (OR) of ORR in first line studies and pooled HR of PFS and OR of ORR for second line studies. Additionally, OS for second line agents were reported in the qualitative analysis. Results: Overall, first line studies comprised 8335 patients (13 studies) and second line studies comprised 4612 patients (11 studies). In the first line setting, atezolizumab plus bevacizumab was associated with the highest OS benefit over sorafenib (HR 0.58, 95% CI, 0.42-0.80; P-score 0.993). Additionally, lenvatinib was associated with the greatest ORR benefit (OR 3.34, 95% CI, 2.17-5.14; P-score 0.080) in the first line setting. In the second line setting, cabozantinib was associated with the highest PFS benefit over placebo (HR 0.44, 95% CI, 0.29-0.66; P-score 0.854) as well as the highest ORR benefit (OR 9.40, 95% CI, 1.25-70.83, P-score, 0.266). Conclusion: Atezolizumab plus bevacizumab appears to have superior efficacy among first line agents whereas cabozantinib appears to be superior in the second line setting. Further studies are warranted to determine whether the type of prior therapy received affects the efficacy of subsequent second line therapy.
Thoracic Cancer
Background: Durvalumab consolidation is associated with improved survival following concurrent chemoradiotherapy (CCRT) in patients with stage III non-small cell lung cancer (NSCLC). Given the heterogeneity of stage III NSCLC patients, in this study we evaluated the efficacy and safety of durvalumab in the real-world setting. Method: Unresectable stage III NSCLC patients were retrospectively studied: one cohort received CCRT, another had CCRT-durvalumab. Primary endpoints were progression-free survival (PFS) and overall survival (OS), secondary endpoints were relapse rate and safety. In CCRT-durvalumab cohort, association between blood markers with survival and pneumonitis risk were analyzed. Results: A total of 84 patients were enrolled: 45 received CCRT, and 39 received CCRT-durvalumab. Median PFS was 17.5 months for CCRT-durvalumab and 8.9 months for CCRT-alone (HR 0.47, p = 0.038). Median OS was not-reached for CCRT-durvalumab and 22.3 months for CCRT-alone (HR 0.35, p = 0.024). Both EGFR-positive and wild-type (WT) patients had numerically improved PFS with durvalumab consolidation compared to CCRT-alone, 17.5 versus 10.9 months and 11.8 versus 6.63 months, respectively (interaction p-value = 0.608). Grade 2+ pneumonitis was detected in 25% of patients in the durvalumab cohort. Most pneumonitis occurred at 3.5 weeks after durvalumab initiation. Baseline neutrophil-to-lymphocyte ratio (NLR) ≥ 3 and ≥5 were associated with shorter PFS with durvalumab. Week 6 platelet-lymphocyte-ratio ≥ 180 was associated with a lower risk of pneumonitis. Conclusion: In this real-world study, durvalumab consolidation post CCRT was associated with a statistically significant improvement in PFS and OS. Effect of durvalumab on PFS was not modified by EGFR status. Active surveillance for pneumonitis is crucial. Baseline NLR may help to predict the benefit of treatment with durvalumab.
Clinical Lung …, 2011
The optimal treatment of locally advanced non-small-cell lung cancer (NSCLC) remains controversial. We hypothesized that using a trimodality approach in selected patients with stage IIIA/IIIB disease would be both feasible and efficacious with reasonable toxicity. Patients/Methods: We enrolled 13 patients with resectable stage III NSCLC on a prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m 2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m 2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Results: All patients responded to induction chemoradiotherapy as measured by total gross tumor volume reductions of 43% on average (range, 27%-64%). Twelve patients underwent resection of the tumor and involved nodes, yielding a resectability rate of 92%. The primary endpoint of 2-year overall survival (OS) was 72% (95% confidence interval [CI], 36%-90%), and 2-year progression-free survival (PFS) was 36% (95% CI, 9%-64%). The maximal toxicity observed per patient was grade II in 5 patients (38%); grade III in 7 patients (54%); grade IV in 1 patient (8%); and grade V in none. Conclusion: This trimodality approach resulted in promising outcomes with reasonable toxicity in carefully selected patients with stage III NSCLC at a single institution.
Radiology and Oncology, 2021
Background. Chemoradiotherapy (ChT-RT) followed by 12-month durvalumab is the new standard treatment for unresectable stage III non-small cell lung cancer. Survival data for patients from everyday routine clinical practice is scarce, as well as potential impact on treatment efficacy of sequential or concomitant chemotherapy and the usage of gemcitabine. Patients and methods. We retrospectively analysed unresectable stage III NSCLC patients who were treated with durvalumab after radical concurrent or sequential chemotherapy (ChT) from December 2017 and completed treatment until December 2020. We assessed progression free survival (PFS), overall survival (OS) and toxicity regarding baseline characteristic of patients. Results. Eighty-five patients with median age of 63 years of which 70.6% were male, 56.5% in stage IIIB and 58.8% with squamous cell carcinoma, were included in the analysis. Thirty-one patients received sequential ChT only, 51 patients received induction and concurrent ChT and 3 patients received concurrent ChT only. Seventy-nine patients (92.9%) received gemcitabine and cisplatin as induction chemotherapy and switched to etoposide and cisplatin during concurrent treatment with radiotherapy (RT). Patients started durvalumab after a median of 57 days (range 12-99 days) from the end of the RT and were treated with the median of 10.8 (range 0.5-12 months) months. Forty-one patients (48.2%) completed treatment with planned 12-month therapy, 25 patients (29.4%) completed treatment early due to the toxicity and 16 patients (18.8%) due to the disease progression. Median PFS was 22.0 months, 12-and estimated 24-month PFS were 71% (95% CI: 61.2-80.8%) and 45.8% (95% CI: 32.7-58.9%). With the median follow-up time of 23 months (range 2-35 months), median OS has not been reached. Twelve-and estimated 24-month OS were 86.7% (95% CI: 79.5-93.9%) and 68.6% (95% CI: 57.2-79.9%). Conclusions. Our survival data are comparable with published research as well as with recently published real-world reports. Additionally, the regimen with gemcitabine and platinum-based chemotherapy as induction treatment was efficient and well tolerated.
Lung Cancer, 2020
Introduction: Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective. Methods: A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups. Results: Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of 138,920perQALYversustheplacebotreatment.One−waysensitivityanalysisrevealedthattheutilityvaluesoftwotreatments,bodyweight,andunitcostofdurvalumabhavethegreatestinfluenceontheresult.Subgroupanalysesdemonstratedthatdurvalumabwasmorecosteffectiveforpatientswithnon−squamous−celllungcancer,followedby25138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of 138,920perQALYversustheplacebotreatment.One−waysensitivityanalysisrevealedthattheutilityvaluesoftwotreatments,bodyweight,andunitcostofdurvalumabhavethegreatestinfluenceontheresult.Subgroupanalysesdemonstratedthatdurvalumabwasmorecosteffectiveforpatientswithnon−squamous−celllungcancer,followedby25150,000 per QALY Conclusion: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies. chemoradiotherapy [4]. However, after completion of chemoradiotherapy, most patients suffer from disease progression, with the five-year survival rate only about 15-30% [4,5]. Recently, immunotherapies, including anti-programmed death 1 (PD-1) and anti-programmed death ligand 1 (PD-L1), have emerged as new paradigms for treating cancer including advanced NSCLC [6-8]. In the phase III PACIFIC trial, a major breakthrough was the use of immunotherapies earlier in the NSCLC treatment [9]. In this randomized clinical trial, patients with unresectable stage III NSCLC whose cancer