頭頸部進行扁平上皮癌に対するCarboplatin+PEP療法とCDDP+PEP療法の無作為化比較試験

抄録

Patients (pts) from 35 institutions, with untreated squamous cell carcinoma of the head and neck at Stage III or IV were treated in this trial between December, 1986 and September, 1987. All pts were centrally randomized to receive either carboplatin (JM-8) 400mg/m₂ i. v. on day 1 (arm A) or cisplatin (CDDP) 50mg/m₂ on day 1 (arm B), together with peplomycin (PEP) 5mg/day i. m. on days 2-6. In principle, 2 courses of either regimen were given to each pt. Out of 91 pts registered, 83 pts (91%) were evaluable for response and toxicity. All pts required hydration in arm B, compared to 7 pts in arm A. In arm A, no pts obtained a complete response (CR) and 15 obtained a partial response (PR) with a response rate of 33%, while in arm B, 1 pt obtained a CR and 12 obtained a PR with a response rate of 34%. The response rates between the 2 regimens were not statistically different. The incidence of nausea and vomiting was significantly higher (p<0.01) in arm B than in arm A. Leukopenia and thrombocytopenia occurred in 22% and 31% of the arm A pts versus 13% and 18% in arm B patients. Renal toxicity, observed as decreased creatinine clearance, occurred in 19% of the arm A pts versus 33% of arm B patients. However, the above toxicities are generally mild and transient. It was concluded that JM-8+PEP suggested activity similar to CDDP+PEP, and also could be safely used at an outpatient level.