Paclitaxel, cisplatin, and 5-fluorouracil for patients with advanced or recurrent squamous cell carcinoma of the head and neck

Hussain, Maha; Gadgeel, Shirish M.; Küçük, Ömer; Du, Wei; Salwen, Walter A.; Ensley, John F.

doi:10.1002/(sici)1097-0142(19991201)86:11<2364::aid-cncr26>3.0.co;2-3

Cited by 35 publications

(12 citation statements)

References 11 publications

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“…Despite the administrative and toxicity profile complexity of the MVAC regimen, our response rate of 46% and 1‐year survival rate of 43% compares favorably with recent studies using paclitaxel/cisplatin/5‐fluorouracil and paclitaxel/ifosfamide/cisplatin regimens with 1‐year survival rates of 37% and 41%, respectively 20, 21. What is lacking in our study, as well as in other studies, are data on quality of life.…”

Section: Discussionsupporting

confidence: 65%

Phase II study of methotrexate, vinblastine, doxorubicin, and cisplatin in patients with squamous cell carcinoma of the upper respiratory or alimentary passages of the head and neck

Okuno

Mailliard

Suman

et al. 2002

Cancer

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BACKGROUND The chemotherapy drugs methotrexate, vinblastine, doxorubicin, and cisplatin have shown activity in patients with recurrent or metastatic squamous cell carcinoma arising from the upper respiratory or alimentary passages of the head and neck. This study was undertaken to assess the antitumor activity and toxicity profile of the drug combination methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) in this patient population. METHODS Patients with histologically confirmed unresectable, recurrent, or metastatic squamous cell carcinoma arising from the upper respiratory or alimentary passages of the head and neck were treated with MVAC over a 4‐week cycle. The doses were as follows: 30 mg/m2 of methotrexate on Days 1, 15, and 22; 3 mg/m2 of vinblastine on Days 2, 15, and 22; 30 mg/m2 of doxorubicin on Day 2; and 70 mg/m2 of cisplatin on Day 2. The total cumulative dose of doxorubicin was not to exceed 450 mg/m2. Treatment was discontinued after four cycles for those whose disease remained stable. Patients were evaluated for chemotherapy response, progression free survival, and survival. RESULTS Thirty‐six patients were accrued onto this study between April 1993 and February 1996. One patient (3%) with a history of cardiac heart failure was declared ineligible. Severe leukopenia (leukocyte count < 2000 cells/m3) was observed in 55% of the patients during the first cycle of treatment and in 81% of the patients during the entire course of their treatment. The overall objective response rate over the first 4 cycles of treatment was 46% (90% confidence interval [CI], 33–60%). Two of the 18 patients who responded had a complete response. The median time to progression was 19 weeks, and 1‐year progression free survival rate was 17% (95% CI, 8–36%). The median survival was 49 weeks, and the 1‐year survival rate was 43% (95% CI, 29–63%). Among the 22 patients with unresected residual or recurrent disease, the median time to progression was 11 weeks, and 1‐year progression free survival rate was 14% (95% CI, 5–39%), and median survival was 24 weeks, and the 1‐year survival rate was 36% (95% CI, 21–63%). Among the 13 patients with metastatic disease, the median time to progression was 26 weeks, and the 1‐year progression free survival rate was 23% (95% CI, 9–62%), the median survival was 54 weeks, and the 1‐year survival rate was 54% (95% CI, 33–89%). CONCLUSIONS Methotrexate, vinblastine, doxorubicin, and cisplatin is an active chemotherapy regimen in patients with recurrent or metastatic squamous cell cancer arising from the upper respiratory or alimentary passages of the head and neck. Cancer 2002;94:2224–31. © 2002 American Cancer Society. DOI 10.1002/cncr.10442

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Section: Discussionsupporting

confidence: 65%

Phase II study of methotrexate, vinblastine, doxorubicin, and cisplatin in patients with squamous cell carcinoma of the upper respiratory or alimentary passages of the head and neck

Okuno

Mailliard

Suman

et al. 2002

Cancer

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“…The median number of cycles administered and the dose intensity achieved for all four study agents highlight the feasibility of this regimen (the primary objective of the current trial). For both cisplatin and paclitaxel, median dose intensities and median total doses were equivalent to those reported previously,11–17, 26 but the duration of treatment was significantly shorter in the current study.…”

Section: Discussionsupporting

confidence: 80%

“…The observed response rate and median OS, both of which were somewhat higher than those consistently reported in association with the standard cisplatin/5‐FU regimen in this setting, are noteworthy 5, 6. Compared with other paclitaxel‐containing combinations, the current regimen was equally active in the induction setting15–17 but had a higher level of activity in patients with recurrent disease 11–14. This finding also holds true for the comparison of the study regimen with docetaxel‐containing regimens 24, 25.…”

Section: Discussionsupporting

confidence: 50%

“…The taxanes, used as single agents or in combination with other cytotoxic agents, have demonstrated activity in patients with HNSCC 10. Cisplatin + paclitaxel, with or without 5‐FU, yielded response rates of 21–38% in patients with recurrent disease11–14 and response rates of 60–88% in patients with unresectable disease 15–17. The main side effect of paclitaxel in combination with cisplatin is peripheral neuropathy, and mucositis and diarrhea are observed when 5‐FU is included in the regimen.…”

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confidence: 99%

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Phase II trial of dose‐dense paclitaxel, cisplatin, 5‐fluorouracil, and leucovorin with filgrastim support in patients with squamous cell carcinoma of the head and neck

Hitt

Jimeno

Millán

et al. 2004

Cancer

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BACKGROUND The current study evaluated the feasibility and clinical activity of a combination of paclitaxel, cisplatin, 5‐fluorouracil (5‐FU), and leucovorin administered on a biweekly schedule to patients with recurrent or unresectable squamous cell carcinoma of the head and neck (HNSCC). METHODS Patients with recurrent or unresectable HNSCC were eligible if they had received a previous regimen of neoadjuvant chemotherapy, concurrent chemoradiotherapy, or no previous systemic therapy. Patients received paclitaxel (175 mg/m2 on Day 1), cisplatin (35 mg/m2 on Days 1 and 2), leucovorin (200 mg/m2 on Day 1), and 5‐FU (1000 mg/m2 per day as a 48‐hour continuous intravenous infusion on Days 1 and 2) every 2 weeks. Patients received subcutaneous filgrastim (300 μg per day) on Days 3–9 of each cycle. Treatment was administered on an outpatient basis for a maximum of six cycles. RESULTS Thirty‐five patients received a combined total of 194 treatment cycles. Eighteen complete responses (51%) and 12 partial responses (34%) were documented, for an overall response rate of 86% (30 of 35 patients). The median progression‐free survival duration was 14 months, and the median overall survival duration was 18 months. Two toxicity‐related deaths were documented (one due to neutropenic sepsis and the other due to catheter‐related pulmonary embolism). Grade 4 neutropenia was observed in one patient. Other severe (Grade 3 or 4) toxic effects included mucositis (14%), anemia (6%), thrombosis (6%), thrombocytopenia (3%), and neuropathy (3%). CONCLUSIONS The current dose‐dense, four‐agent, taxane‐containing biweekly schedule was feasible and effective in patients with recurrent or unresectable HNSCC. However, given the single‐center nature of the current study and the highly selected study population, further validation of these findings is recommended. Cancer 2004. © 2004 American Cancer Society.

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“…Depending on the patient population treated, response rates ranged from 40 to 60%, with moderate response duration in some patients [28][29][30][31][32]40,41]. Depending on the patient population treated, response rates ranged from 40 to 60%, with moderate response duration in some patients [28][29][30][31][32]40,41].…”

Section: Taxanes In Combination With Other Chemotherapy Agentsmentioning

confidence: 99%

Taxanes in cancer of the head and neck

Misiukiewicz¹,

Gupta

Bakst

et al. 2014

Anti-Cancer Drugs

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Accumulating evidence from clinical trials has shown that taxanes are among the most active antitumor agents currently available for squamous cell carcinoma of the head and neck. They are strong enhancers of the efficacy of radiotherapy in locally advanced cancer and are highly potent chemotherapeutic agents in recurrent/metastatic settings. Paclitaxel and docetaxel, prototypes of taxanes, are already well known and used in the treatment of squamous cell carcinoma of the head and neck, but a newer generation of taxanes is emerging and may possess stronger antitumor activity and/or decreased normal tissue toxicity. Acquired resistance to taxanes has become one of the major therapeutic obstacles, which hopefully will be overcome with a newer generation of taxanes, as our knowledge of the mechanism of resistance has improved.

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Paclitaxel, cisplatin, and 5-fluorouracil for patients with advanced or recurrent squamous cell carcinoma of the head and neck

Cited by 35 publications

References 11 publications

Phase II study of methotrexate, vinblastine, doxorubicin, and cisplatin in patients with squamous cell carcinoma of the upper respiratory or alimentary passages of the head and neck

Phase II study of methotrexate, vinblastine, doxorubicin, and cisplatin in patients with squamous cell carcinoma of the upper respiratory or alimentary passages of the head and neck

Phase II trial of dose‐dense paclitaxel, cisplatin, 5‐fluorouracil, and leucovorin with filgrastim support in patients with squamous cell carcinoma of the head and neck

Taxanes in cancer of the head and neck

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