Phase II trial of cisplatin and capecitabine in patients with squamous cell carcinoma of the head and neck, and correlative study of angiogenic factors (original) (raw)
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Head and Neck-journal for The Sciences and Specialties of The Head and Neck, 2002
Objective.We assessed the response rate and the toxicity of cisplatin plus vinorelbine in patients with this condition.We assessed the response rate and the toxicity of cisplatin plus vinorelbine in patients with this condition.Patients and Method.Forty-two patients were included. Therapy consisted of cisplatin, 100 mg/m2 on day 1, and vinorelbine, 25 mg/m2 on days 1 and 8, given every 21 days. Therapy was continued up to six courses or progressive disease.Forty-two patients were included. Therapy consisted of cisplatin, 100 mg/m2 on day 1, and vinorelbine, 25 mg/m2 on days 1 and 8, given every 21 days. Therapy was continued up to six courses or progressive disease.Results.One hundred fifty-nine courses were given (median, three per patient). Dose reduction was applied in 13% of courses and 43% of patients. Grade 3 to 4 neutropenia appeared in 11% of courses and 35% of the patients. One patient died of febrile neutropenia. Ten percent of patients attained a complete response, and 23% attained a partial response (overall 33%, 95%CI 19%–47%). The median duration of response and median survival were 6 months. Twenty-four percent of patients remain alive at 1 year.One hundred fifty-nine courses were given (median, three per patient). Dose reduction was applied in 13% of courses and 43% of patients. Grade 3 to 4 neutropenia appeared in 11% of courses and 35% of the patients. One patient died of febrile neutropenia. Ten percent of patients attained a complete response, and 23% attained a partial response (overall 33%, 95%CI 19%–47%). The median duration of response and median survival were 6 months. Twenty-four percent of patients remain alive at 1 year.Conclusions.The combination of cisplatin and vinorelbine is moderately active in patients with recurrent or metastatic carcinomas of the head and neck and avoids the inconvenience of prolonged infusions of 5-fluorouracil. © 2002 Wiley Periodicals, Inc. Head Neck 24: 1054–1059, 2002The combination of cisplatin and vinorelbine is moderately active in patients with recurrent or metastatic carcinomas of the head and neck and avoids the inconvenience of prolonged infusions of 5-fluorouracil. © 2002 Wiley Periodicals, Inc. Head Neck 24: 1054–1059, 2002
Protocols, 2014
Aims & Objectives: To assess the immediate loco regional response rate and acute toxicity in patients with locally advanced squamous cell carcinoma of the head and neck in Conventional radiotherapy with weekly Cisplatin and Capecitabine. Materials and Methodology: Single arm prospective study with 30 consecutive patients with locally advanced head and neck cancer presented to our hospital. All patients were treated with conventional radiotherapy 66Gy along with weekly Inj. Cisplatin 40mg/m2 and T. capecitabine 500mg/m2 twice daily along with radiation. The immediate locoregional response rates were assessed clinically and radiologically 6 weeks after concurrent chemoradiotherapy. The toxicity profile of the treatment was assessed with RTOG acute morbidity scoring criteria and CTCAE Version 4. The study was statistically analysed using Chi Square test. Results: Among 30 patients, Ca Oropharynx was 9 patients, followed by Ca Hypopharynx 8 patients, Ca Oral cavity with 7 patients and Ca Supraglottis 6 patients.73% of patients had complete response and 27% had partial response. Toxicities observed in the study were Mucositis grade 3 in 5 patients and grade 4 in 2 patients; Skin reactions grade 2 in 2 patients. Leucopenia grade 2 in 2 patients. Systemic toxicity diarrheagrade1 was only in 2 patients. There was no renal toxicity, hand foot syndrome in this study. There was no treatment related deaths in this study. Conclusion: Concurrent chemo radiotherapy with Inj. Cisplatin and T.Capecitabine in locally advanced squamous cell carcinoma of head and neck cancer is better regimen with manageable toxicity with higher complete response rate.
Cancer Chemotherapy and Pharmacology, 2010
Purpose The eYcacy and safety of gemcitabine in combination with cisplatin (GC) as the Wrst-line treatment in patients with recurrent/metastatic (R/M) squamous cell carcinoma of head and neck (SCCHN) was examined. Patients and methods Patients with R/M SCCHN without prior treatment for their R/M disease were eligible and treated with gemcitabine 1,250 mg/m 2 on day 1, day 8 and cisplatin 80 mg/m 2 on day 8 every 21 days. Results Forty patients were enrolled from March 2004 to January 2006, and 30 were evaluable for treatment eVectiveness and outcome. The median age of evaluable patients was 50 years and all patients were male. Partial response was observed in 9 (30%) and stable disease in 7 (23.3%) patients. The overall response rate and disease control rate was 30 and 53.3%, respectively. The major toxic eVects were ¸grade 3 leukopenia and anemia (65 and 27.5%, respectively). With a follow-up of 72 months, the median time to progression (TTP) was 128 days (95% CI, 78-242) and median overall survival (OS) was 401 days (95% CI, 216 »not reached). Conclusions This GC regimen demonstrates a good activity and a promising survival period in patients with R/M SCCHN.
Cancer, 2016
The combination of cisplatin, 5-fluorouracil, and cetuximab is a standard treatment for patients with recurrent/metastatic head and neck cancer, with a high rate of toxicity. Identifying less toxic, equally effective regimens is imperative. Therefore, in the current study, the authors investigated first-line treatment with an all-oral regimen of capecitabine and lapatinib. Patients were required to have incurable head and neck cancer of any primary site other than the nasopharynx, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2, and no prior exposure to capecitabine or lapatinib. Subjects were treated with capecitabine at a dose of 1000 mg/m(2) twice daily and lapatinib at a dose of 1250 mg daily. Capecitabine was administered for 14 days of each 21-day cycle for 4 cycles. Lapatinib was administered daily until disease progression. The primary outcome was overall survival. A total of 44 subjects were accrued between November 13, 2009 and April 29, 2014. ...
BACKGROUND: Aim of my study is to compare the response and toxicity profile of squamous cell carcinoma of Head & Neck(SCHNC) patients when in concurrent chemoradiation(CTRT) Capectabine is combined with cisplatin vs cisplatin alone. METHODS: 55 patients of stage III/IV nonmetastatic SCHNC patients were either treated with CTRT with Cisplatin & Capecitabine arm(Arm A, n=29), or with Cisplatin (Arm B, n=26). In both the arm Radiotherapy dose was 66-70 Gy in conventional fractionation. Response was assessed by RECIST criteria after 6 wks of completion of treatment and acute toxicities by the RTOG/EORTC guideline. Keywords: CAPECITABINE CISPLATIN CHEMORADIATION
Japanese Journal of Clinical Oncology, 2009
Objective: Prognosis in patients with recurrent or metastatic squamous cell carcinoma of the head and neck is poor, and systemic chemotherapy has an only modest impact on the outcome. Chemotherapy with cisplatin plus 5-FU (PF) is widely used, but the standard dosage, PF (100/1000; cisplatin 100 mg/m 2 day 1 and 5-FU 1000 mg/m 2 /24 h by continuous intravenous infusion on days 1 through 4), is relatively toxic for palliative use, and PF (80/800; cisplatin 80 mg/m 2 day 1 and 5-FU 800 mg/m 2 /24 h by continuous intravenous infusion on days 1 through 5) is more commonly used in Japan, albeit without clear comparative data. We retrospectively analyzed the efficacy and safety of this regimen in our institution. Methods: Thirty of 43 patients with recurrent or metastatic head and neck cancer treated with PF in our institution between 2001 and 2006 were analyzed. Entry criteria included histologically proven squamous cell carcinoma and recurrent or metastatic disease. Results: The most common chemotherapy-related Grade 3 or 4 toxicities were nausea (16.6%), anorexia (40%), stomatitis (6.6%) and leukopenia (10%), all of which were manageable. Complete response was achieved in one patient and partial response in eight, giving an overall response rate of 30%. Median progression-free survival was 3.0 months. Estimated 2-year survival rate was 16.7% and median overall survival was 9.8 months. Of the 30 patients, 5 (16.7%) survived more than 2 years, all of whom had primary oropharyngeal cancer. Conclusions: In this retrospective analysis, chemotherapy with PF (80/800) for recurrent or metastatic head and neck cancer appeared to have equal efficacy and better safety than PF (100/1000).
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, 1997
The goal of the present analyses is to assess the association between different therapeutic approaches and both the probability of achieving a complete response and the risk of death in patients with stage III-IV, inoperable, squamous cell carcinoma of the head and neck (SCC-HN). Between August 1983 and December 1990, 273 patients with stage III-IV, previously untreated, unresectable SCC of the oral cavity, pharynx and larynx, were included into two consecutive randomized multi-institutional trials (HN-7 and HN-8 protocols) coordinated by the National Institute for Cancer Research (NICR) of Genoa. The HN-7 protocol compared neo-adjuvant chemotherapy (four cycles of vinblastine, 6 mg/m2 i.v. followed by bleomycin, 30 IU i.m. six hours later, day 1; methotrexate, 200 mg i.v., day 2; leucovorin, 45 mg orally, day 3) (VBM) followed by standard radiotherapy (70-75 Gy in 7-8 weeks) (55 patients) to alternating chemoradiotherapy based on four cycles of the same chemotherapy alternated with...
Japanese journal of clinical oncology, 2014
A randomized Phase II/III study was launched in Japan to evaluate the non-inferiority of concurrent chemoradiotherapy with weekly cisplatin (40 mg/m(2)) compared with concurrent chemoradiotherapy with 3-weekly cisplatin (100 mg/m(2)) for post-operative high-risk patients with locally advanced squamous cell carcinoma of head and neck. This study began in October 2012, and a total of 260 patients will be accrued from 18 institutions within 5 years. The primary endpoint of the Phase II part is proportion of treatment completion and that of the Phase III part is overall survival. The secondary endpoints are relapse-free survival, local relapse-free survival, nutrition-support-free survival, non-hospitalized treatment period during permissible treatment period and adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009125 [http://www.umin.ac.jp/ctr/\].