ABSTRACT
Fifty-four previously untreated patients with locally advanced resectable squamous cell carcinoma of the head and neck (SCCHN) were enrolled into a prospective randomized controlled trial to evaluate whether induction chemotherapy improves the disease-free survival compared to the standard treatment (surgery + radiation). Thirty patients received chemotherapy, which consisted of cisplatin 20 mg/m2 day 1-5, bleomycin 10 mg/m2, continuous infusion from day 3-7, and methotrexate 40 mg/m2 given on day 15 and day 22. The cycle was repeated on day 29 for two cycles. Twenty patients completed chemotherapy courses. Overall response rate was 77% (23 of 30). No survival improvement was observed. Kaplan-Meier analysis indicated survival (and 95% confidence interval) at 3 years was 57% (29%-84%) for the control group and 60% (34%-87%) for the chemotherapy group, and 57% (29%-84%) and 45% (12%-78%) at 4 years (P = 0.736). However, patients who had a complete response were significantly better in terms of long-term survivors (5 of 7 patients were still alive), in contrast to patients who had partial responses among whom only 4 of 16 were alive. Toxicities of this induction protocol are tolerable; one chemotherapy-related death occurred from profound thrombocytopenia. If efforts in determining a chemotherapy-sensitive patient were successfully established, along with a better sequence and the discovery of new and safer drugs, survival of SCCHN should be much improved.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Head and Neck Neoplasms/drug therapy , Aged , Bleomycin/administration & dosage , Carcinoma, Squamous Cell/mortality , Cisplatin/administration & dosage , Drug Administration Schedule , Female , Head and Neck Neoplasms/mortality , Humans , Infusions, Intravenous , Male , Methotrexate/administration & dosage , Middle Aged , Preoperative Care , Prospective Studies , Survival RateABSTRACT
A prospective randomized phase III trial was carried out at Songklanagarind Hospital from August 1988 to December 1990. The objectives of the study were to evaluate the effect of chemotherapy regimen in squamous cell carcinoma of the esophagus and to determine whether induction chemotherapy improves symptom-free period and survival in these patients compared to surgical treatment alone. Twenty-four patients were randomized to receive 2 cycles of chemotherapy, cis-platinum 100 mg/m2 intravenously on day 1, bleomycin 10 mg/m2 loading dose on day 3, followed by 10 mg/m2/day continuous intravenous infusion on days 4 through 7, and vinblastine 3 mg/m2 given intravenously on days 1, 8, 15, 22. The cycle was repeated on day 29. Fifteen patients completed 2 courses of chemotherapy and among these, 2 patients had a complete clinical response (13%), 6 (40%) had a partial response, and 7 patients (47%) had no response. Four patients died during chemotherapy treatment. Grade 3 hematologic toxicity (ECOG criteria) was observed in 47% (7/15) of patients. Twenty-two patients were randomized to conventional treatment (surgery alone). Median survival time was 17 months in both groups. However, early survival appeared to be better in the control group. Kaplan-Meier survivals at 6 months were 69% and 89% and at 3 years were 31% and 36% for the induction chemotherapy group and control group, respectively. The survival time differences were not statistically significant (P = 0.186). These findings demonstrate that although this chemotherapy regimen had some effect on squamous cell carcinoma of esophagus, it did not improve survival. On the contrary, survival seems to be better in the control group. The 6-month survival discrepancy between both groups might be due to the poor nutritional status of our patients, who may better tolerate smaller dosages of chemotherapy.
