肺小細胞癌の化学療法の関する研究―肺小細胞癌に対するCAV-PVP hybrid療法とCAV-PVP sequential療法の無作為化比較試験―

One hundred and forty three patients with previously untreated SCLC were randomly allocated to receive either the CAV-PVP hybrid (Hyb) regimen or CAV-PVP sequential(Seq) regimen between November 1987 and October 1992. The Hyb regimen consisted of CAV (cyclophosphamide 700mg/㎡,iv,day 1 ; adriamycin 30mg/㎡,iv,day 1 ; and vincristine 1.4mg/㎡,iv,day 1) and PVP (cisplatin 60mg/㎡,iv,day 8 ; and etoposide 100mg/㎡,iv,days 8 and 9), and was repeated up to 6 cycles at 4-week intervals. The Seq regimen consisted of an initial 3 cycles of CAV (cyclophosphamide 700mg/㎡,iv,days 1 and 8 ; adriamycin 30mg/㎡,iv days 1 and 8 ; and vincristine 1.4mg/㎡,iv,day 8 ; and vincristine 1.4mg/㎡,iv days 1 and 8) followed by 3 cycles of PVP (cisplatin 60mg/㎡,iv,days 1 and 8 ; and etoposide 100mg/㎡,iv,days 1, 2, 8 and 9) at 4-week intervals. For patients with limited disease (LD), thoracic irradiation at a dose of 50 Gy was given after a maximal response with chemotherapy, and LD patients achieving a complete response (CR) received prophylactic cranial irradiation at a dose of 30 Gy. For the LD patients, the overall response rate was 97% for the Hyb regimen with a CR rate of 59% and 100% for the Seq regimen with a CR rate of 45%. For the patients with extensive disease (ED), the overall response rate was 94% for the Hyb regimen with a CR rate of 21% and 78% for the Seq regimen with a CR rate of 16%. The median survival time (MST) for the LD patients was 17.9 months for the Hyb group and 20.9 months for the Seq group, and the MST for the ED patients was 9.7 months for the Hyb group and 12.2 months for the Seq group. The 3-year survival rate for the LD patients was 21.9% for the Hyb group and 18.8% for the Seq group. There was a trend favoring the Hyb regimen in terms of overal response rate, CR rate, and 3-year survival rate for the LD patients as well, but there was no significant difference in survival between the two treatment groups. Hematologic toxicity was the major dose-limiting toxicity, but it was generally well-tolerated in both treatment groups. These findings indicate that both Hyb and Seq regimens are equally effective for the prolongation of life in patients with SCLC.

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