Treatment with cisplatin and fluorouracil alternating with radiation favourably affects prognosis of inoperable squamous cell carcinoma of the head and neck: results of a multivariate analysis on 273 patients (original) (raw)
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Acta Oncologica, 1991
A phase zyxwvutsrq 11 study was made of 58 consecutive patients with previously untreated locally advanced squamous cell carcinomas of the head and neck. The induction chemotherapy consisted of 3 courses of cisplatin (100 mg/m2) and a subsequent 120-h infusion of 5-fluorouracil (1 zyxwvutsrqp OOO mg/m2/24 h) repeated every 3 weeks. It was followed by radiotherapy to a median target dose of zyxwvuts 66 Gy and surgery for residual tumour. A total of 91 per cent received all 3 courses of chemotherapy, which was well tolerated. Complete response (CR) was obtained in 20 patients (35%) after chemotherapy and in 40 patients (69%) after subsequent radiotherapy. The median observation time was 28 months (range 15-57). The actuarial survival at 2 years for complete responders to chemotherapy was 83 per cent, implying a prolonged survival (p=0.002) compared to those with less than CR. Complete responders after chemotherapy had also a significantly longer recurrence-free survival, though 19 out of 20 did not undergo surgery. Complete response after this induction therapy is thus an important prognostic predictor.
European Archives of Oto-Rhino-Laryngology, 1992
Treatment results of irradiation as a single treatment for advanced stage IV unresectable head and neck cancer remains uniformly poor and apparently has not changed with the most recent improvements in oncological care. Despite several negative results of randomized studies, neoadjuvant or concomitant chemotherapy and radiotherapy seems to improve the number of complete responses and also the duration of disease-free survival. The present study was designed to determine the feasibility, potential risks and benefits of the two methods of combined treatment and radiotherapy alone on the management of advanced unresectable squamous cell carcinoma of the upper respiratory and digestive system. From 1983 to 1986, 90 patients entered the trial. Thirty patients were randomized to each study group: radiotherapy alone (70 Gy); neoadjuvant chemotherapy (vinblastine, mitomycin, cisplatin, and bleomycin) and radiotherapy; concomitant chemotherapy (cisplatin and bleomycin) and radiotherapy. An increased frequency of complete responses (33%) was seen in patients treated with the two different combinations of chemotherapy and irradiation compared to irradiation alone (10%). However, toxicity was more common in patients treated with the two modalities of combined treatment and there were no differences in overall survival rates (P = 0.706).
Cancer, 1991
affiliated institutions conducted a randomized study to compare two different ways of combining chemotherapy (CT) and radiation therapy (RT). One hundred sixteen patients were randomized to receive neoadjuvant CT followed by definitive RT (treatment arm A) or alternating CT and RT. In treatment arm A, RT consisted of 70 Gy to the involved areas and 50 Gy to the uninvolved neck at 2 Gy/fraction, five fractions per week. In treatment arm B, RT consisted of 60 Gy to involved areas and 50 Gy to the uninvolved neck in three courses of 20 Gy each, 2 Gy/fraction, ten fraction& weeks alternated with four courses of CT. CT consisted of vinblastine 6 mg/mz intravenously followed 6 hours later by bleomycin 30 IU intramuscularly, day 1; methotrexate 200 mg intravenously, day 2; leucovorin rescue, day 3. CT was repeated every 2 weeks up to four courses. The same CT was used in both treatment arms of the study. Fifty-five patients were entered in treatment arm A and 61 in treatment arm B. Complete responses were 7/48 and 19/57 in treatment arms A and B, respectively (P < 0.03). Four-year progression-free survival was 4% in treatment arm A and 12% in treatment arm B ( P < 0.02), and four-year survival was 10% in A and 22% in B (P < 0.02). Mucosal tolerance was significantly worse in treatment arm B (P < 0.00004). The subgroup analysis shows the major improvement of alternating CT and RT in patients with the worst prognostic characteristics. Cancer 67:915-921, 1991.
Cancer Detection and Prevention, 2004
This prospective randomised study was undertaken to assess the effects and effectiveness of cisplatin in a pre-operative setting. Thirty-eight patients were treated with stage II-IVa (AJCC) squamous cell cancer of the oral cavity and oropharynx. Nineteen patients received a combination of bleomycin, vincristine, methotrexate (BVM; group I.), 19 received BVM and cisplatin (group II). Patients underwent surgery within 3 weeks after chemotherapy. Biopsy and surgical specimens were compared. A clinical complete response was seen in five patients in group I (26.3%) and in four patients in group II (21.1%). Partial response was noted in 11 patients in group I (57.8%) and in 13 patients in group II (68.4%). There was no statistical difference in clinical response between the two groups. Microscopic response was better in the cisplatin treated group. Median follow up of patients is 52 (36-70) months. Disease free survival showed a significant difference, favouring the no cisplatin group (P = 0.03). There was no significant difference in overall survival (P > 0.6). Cisplatin in combination with BVM showed significantly higher levels of microscopic response, but the lower disease free survival is mostly due to a higher rate of regional neck failure.
Cancer, 1981
Between 1975 and 1978, 23 patients with Stage IV, unresectahle, squamous cell carcinoma ofthe head and neck were randomized to receive radiotherapy (RT, I1 patients), or radiotherapy-chemotherapy I R T & CT, 12 patients). The response rate for the 12 RT & CT patients was four complete remissions (CR) and four partial remissions (PR); the 11 RT patients had one CR and three PR. The presence of a responses (CR or PR) significantly enhanced the median survival (14 vs. 5 months; P = 0.005). The duration of objectives remission was longer among the RT & C T patients when compared with RT patients (6 vs. 2.3 months, P = 0.18). The median survival of the RT & C T group was 12 months compared with 5.6 months for the RT group (P = 0.13). One RT & CT patient remains alive with disease at 44 months, one RT patient remains alive without disease at 30 months. The present chemotherapy regimen did not modify the pattern of failure and only marginally increased patient survival. It did, however, increase the response rate. The authors plan to reactivate the trial with modification in the induction cheniotherapy and the addition of postradiation maintenance CT consisting of sequential bleomycin and cis-platinum.
Oral Oncology, 1997
This protocol was designed to achieve an improvement in the overall and disease-free survival in locally advanced, previously untreated carcinoma of the head and neck. 53 patients (pts) with locally advanced Stages III and IV, MO squamous cell carcinoma of the nasopharynx, larynx, paranasal sinuses, oral cavity, oropharynx, hypopharynx and one of unknown origin were treated with intensive chemotherapy followed shortly thereafter by radiotherapy. Induction chemotherapy consisted of two cycles of cisplatin 100 mg/m' over 60 min on day 1, plus 5FU 1000 mg/m' continuous infusion over 24 h on days 2-5, with a lo-day interval between the two cycles, followed by definitive radiotherapy after 10 days. The overall response rate to chemotherapy was 79%, with a 28% complete response (CR) rate and a 51% partial response (PR) rate. The overall CR rate after radiotherapy was 70%. With a median follow-up period of 48 months, the 5-year actuarial survival and disease-free survival rates were 67% and 45%, respectively. No difference was found in the survival probability of pts with carcinoma of the nasopharynx, larynx or other primary sites. The survival of pts with a performance status (PS) (1 was better than pts with PS>l, 72% versus 51% (not significant). The survival probability of complete responders to chemotherapy was superior than the survival of non-complete responders to chemotherapy, 100% versus 54% [P = O.OOl]. The main toxicity was mucositis during radiotherapy. In conclusion, this treatment regimen demonstrated a high CR rate and survival probability in pts with locally advanced and mostly inoperable head and neck cancer.
International Journal of Radiation Oncology*Biology*Physics, 1992
To test the efficacy of sequential chemotherapy as an adjuvant to surgery and postoperative radiotherapy for patients with locally-advanced but operable squamous cell cancers of the head and neck region, a randomized clinical trial was conducted under the auspices of the Head and Neck Intergroup (Radiation Therapy Oncology Group, Southwest Oncology Group, Eastern Oncology Group, Cancer and Leukemia Group B, Northern California Oncology Group, and Southeast Group). Eligible patients had completely resected tumors of the oral cavity, oropharynx, hypopharynx, or larynx. They were then randomized to receive either three cycles of cis-platinum and 5-FU chemotherapy followed by postoperative radiotherapy (CT/RT) or postoperative radiotherapy alone (RT). Patients were categorized as having either "low-risk" or "high-risk" treatment volumes depending on whether the surgical margin was 2 5 mm, there was extracapsular nodal extension, and/or there was carcinoma-in-situ at the surgical margins. Radiation doses of 50-54 Gy were given to "low-risk" volumes and 60 Gy were given to "highrisk" volumes. A total of 442 analyzable patients were entered into this study with the mean-time-at-risk being 45.7 months at the time of the present analysis. The 4-year actuarial survival rate was 44% on the RT arm and 48% on the CT/RT arm (p = n.s.). Disease-free survival at 4 years was 38% on the RT arm compared to 46% on the CT/RT arm (p = n.s.). At 4 years the local/regional failure rate was 29% vs. 26% for the RT and CX'/RT arms, respectively (p = n.s.). The incidence of first failure in the neck nodes was 10% on the RT arm compared to 5% on the CT/RT arm (p = 0.03 without adjusting for multiple testing) and the overall incidence of distant metastases was 23% on the RT arm compared to 15% on the CT/RT arm (p = 0.03). Treatment related toxicity is discussed in detail, but, in general, the chemotherapy was satisfactorily tolerated and did not affect the ability to deliver the subsequent radiotherapy. Implications for future clinical trials are discussed.
Journal of Clinical Oncology, 2006
Purpose Patients with intermediate-stage squamous cell carcinoma of the head and neck traditionally have been treated with initial surgical resection followed by radiotherapy (RT) alone or chemoradiotherapy. A previous study in this patient population reported a 91% locoregional control rate and 65% overall survival (OS) rate at 5 years, with chemoradiotherapy used as primary treatment. This study was undertaken to assess whether shortening treatment duration with hyperfractionated RT would be feasible and improve locoregional control, organ preservation, and progression-free survival. Methods Eligible patients with stage II or III disease received fluorouracil, hydroxyurea, and RT given twice daily on a week-on/week-off schedule. Quality-of-life scores were measured using three validated indexes. Results All 53 patients enrolled are included in the analysis, with a median follow-up of 42 months (range, 5 to 98 months). Grade 3 or 4 in-field mucositis was observed in 77% and 9%, res...