Intensive concomitant chemoradiotherapy in locally advanced unresectable squamous cell carcinoma of the head and neck: a phase II study of radiotherapy with cisplatin and 7-week continuous infusional fluorouracil.

Wibault, P.; Bensmaïne, Mohamed-El-Amine; Forni, M; Armand, J.P.; Bernal, Eduardo Téllez; Guillot, T.; Recondo, Gonzálo; Domenge, C.; Janot, F; Borel, C.; Luboinski, B.; Eschwege, F; Cvitkovic, Esteban

doi:10.1200/jco.1996.14.4.1192

Cited by 25 publications

(15 citation statements)

References 40 publications

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“…We find our response rate and survival data are comparable to those reported by others who delivered full doses of chemotherapy concurrent with radiotherapy, but with increased toxicities [11, 12]. Likewise, the 73% pathological CR rate is comparable to published chemoradiotherapy reports in which full doses of the drug were delivered [13, 14].…”

Section: Discussionsupporting

confidence: 77%

Concurrent Chemoradiotherapy with Low-Dose Cisplatin plus 5-Fluorouracil for the Treatment of Patients with Unresectable Head and Neck Cancer

et al. 2002

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Objective: The purpose of this study was to determine the efficacy of concurrent chemoradiotherapy using conventional radiotherapy combined with low-dose daily 5-fluorouracil (5FU) and cisplatin (CDDP) for the locally unresectable head and neck cancer patients. Patients and Methods: From September 1996 through December 2000, we carried out a phase II study of concurrent chemoradiotherapy with low-dose CDDP plus 5FU for the treatment of patients with unresectable squamous cell carcinoma of the head and neck. Chemoradiotherapy consisted of irradiation with 1.6–2.0 Gy/day for 5 days per week up to a total dose 68 Gy and CDDP 3 mg/m² by intravenous infusion over 1 h plus 5FU 150 mg/m² by intravenous infusion over 24 h per day for 5 days per week. Results: Ninety percent of the patients had stage IV disease, including 65% of patients with T4 disease. Thirty-three patients (83%) received the full treatment as planned; 39 (98%) received full-dose radiotherapy and 33 (83%) full-dose chemotherapy. Of the 40 patients evaluable for response, 20 (50%) achieved complete response (CR) and 12 (30%) partial response with an overall response rate of 80%. Among the 20 CR patients, 15 underwent endoscopic blind biopsies and 4 had positive lesions. The most frequently observed toxicity was mucositis. Ten patients developed grade III mucositis, and 3 patients required enteral nutritional support through a feeding tube. Grade III leukopenia, anemia and thrombocytopenia were observed in 28, 25 and 20% of the patients, respectively. The median duration of follow-up at the time of analysis was 18 months. The median survival time was 23 months. The responders survived longer (34 months) than the nonresponders (4 months; p < 0.05). Conclusion: This regimen is safe and efficacious in the treatment of patients with advanced unresectable head and neck cancer.

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Section: Discussionsupporting

confidence: 77%

Concurrent Chemoradiotherapy with Low-Dose Cisplatin plus 5-Fluorouracil for the Treatment of Patients with Unresectable Head and Neck Cancer

et al. 2002

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“…In breast and colon cancer patients, it is a reference treatment as well as being the backbone of first-line treatment schemes in many other solid tumors, such as stomach and biliary duct adenocarcinoma. [41][42][43][44][45] The lack of formal studies in head and neck squamous cell cancer other than in the chemoradiotherapy combination 46 may be a gap to fill. We consider that the present results in UCNT patients indicate the need for phase II studies in recurrent/metastatic HNSCC, given the fact that continuous exposure to low dose 5-FU has a different cytotoxic mechanism than bolus administration, modulated or not by folinic acid, 47 and that its tolerance profile makes it a viable alternative in this patient population, with an otherwise poor prognosis.…”

Section: Discussionmentioning

confidence: 99%

Palliative treatment with low-dose continuous infusion 5-fluorouracil in recurrent and/or metastatic undifferentiated nasopharyngeal carcinoma type

et al. 1997

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Significant advances in identification of etiologies of inherited thrombosis have been recently reported. A point mutation in coagulation factor V (factor V Leiden) results in resistance to activated protein C and probably represents the most common genetic risk factor for venous thrombosis. A metabolic disorder, homocysteinemia, is now known to be an important risk factor for both arterial and venous thrombosis. Many patients with recurrent thrombosis will have more than one genetic risk factor identified. Recognition of these new disorders should permit a diagnosis to be achieved in at least half of patients evaluated for inherited thrombosis. Am. J. Hematol. 54:53–60, 1997 © 1997 Wiley‐Liss, Inc.

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“…Often, interruptions in treatment must be sched- uled to permit injured tissues and organs to recover. Such drawbacks have been reported with concomitant radio therapy and chemotherapy, with patients requiring a me dian time of 8 weeks to recover from severe (> grade 3) mucositis [21]. This is particularly critical in treating head and neck carcinomas, because the side effects of mucositis and xerostomia often minimize compliance and hinder the completion of a protocol.…”

Section: Discussionmentioning

confidence: 99%

Amifostine in Simultaneous Radiochemotherapy for Head and Neck Cancer

Büntzel

Küttner

Fröhlich³

et al. 1997

Otorhinolaryngol Nova

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Objective: The efficacy of the selective cytoprotective agent amifostine in patients with stage III or IV head and neck cancer treated with concurrent carboplatin and radiation therapy was evaluated in a randomized phase II trial. Patients and Methods: Thirty-nine patients with squamous cell carcinomas of the head and neck received adjunctive or primary radiotherapy (5 days per week with daily fractions of 2 Gy, up to a total dose of 60 Gy) in conjunction with carboplating (70 mg/m2) on days 1–5 and days 21–25. All patients received radiation, encompassing at least 75% of the major salivary glands. The patients were randomized to receive radiation and carboplatin therapy (RCT) alone or RCT preceded by rapid infusion of amifostine (500 mg) on the days carboplatin was administered. Results and Conclusion: Patients treated with amifostine had significant reductions in mucositis (p = 0.0001) and xerostomia (p = 0.0001) relative to patients treated with RCT alone. None of the 25 patients treated with amifostine but 12 of 14 patients (86%) treated with RCT alone developed grade 3 or 4 mucositis. Additionally, patients in the amifostine plus RCT arm had significantly less severe bone marrow toxicity from carboplatin, thrombocytopenia (p = 0.001) and leukopenia (p = 0.001), relative to patients treated with RCT alone. Of 25 patients in the amifostine arm, 18 (72%) exhibited a complete response and 6 (24%) a partial response as compared with 6 (43%) complete responses and 6 (43%) partial responses in the RCT-alone arm. Selective cytoprotection with amifostine offers substantial protection against the dose-limiting toxicities of RCT for patients with head and neck cancer with no reduction in antitumor effect.

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Intensive concomitant chemoradiotherapy in locally advanced unresectable squamous cell carcinoma of the head and neck: a phase II study of radiotherapy with cisplatin and 7-week continuous infusional fluorouracil.

Cited by 25 publications

References 40 publications

Concurrent Chemoradiotherapy with Low-Dose Cisplatin plus 5-Fluorouracil for the Treatment of Patients with Unresectable Head and Neck Cancer

Concurrent Chemoradiotherapy with Low-Dose Cisplatin plus 5-Fluorouracil for the Treatment of Patients with Unresectable Head and Neck Cancer

Palliative treatment with low-dose continuous infusion 5-fluorouracil in recurrent and/or metastatic undifferentiated nasopharyngeal carcinoma type

Amifostine in Simultaneous Radiochemotherapy for Head and Neck Cancer

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