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Randomized phase III trial of docetaxel and cisplatin combination chemotherapy versus mitomycin, vindesine and cisplatin combination chemotherapy with concurrent thoracic radiation therapy for locally advanced non-small cell lung cancer: Preliminary report.

7101 Background: Standard treatment of locally advanced non-small cell lung cancer (NSCLC) is cisplatin-based chemotherapy with concurrent thoracic radiation therapy (TRT). Furuse et al. demonstrated a superiority of mitomycin, vindesine and cisplatin (MVP) chemotherapy with concurrent TRT over that with sequential TRT (JCO 17, 1999). We demonstrated that docetaxel plus cisplatin (DP) chemotherapy with concurrent TRT shows better response rate and survival (Kiura K et al. BJC 89, 2003). We conducted a randomized phase III trial that compared DP with MVP in locally advanced NSCLC patients when concurrently administered with TRT.


METHODS
We randomly assigned patients with good performance status (PS)-stage IIIA/IIIB NSCLC to receive DP or MVP chemotherapy. Chemotherapy consisted of docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, & 36 in the DP arm and mitomycin 8 mg/m2 on days 1 & 29, vindesine 3 mg/m2 on days 1, 8, 29, & 36, and cisplatin 80 mg/m2 on days 1 & 29 in the MVP arm. In the both groups, TRT began on day 1 at a dose of 60 Gy (2 Gy per fraction and 5 fractions per week for a total of 30 fractions).


RESULTS
Two hundred patients entered the trial between July 2000 and July 2005. Pretreatment characteristics were well balanced between the two treatment arms as follows: male/female 92/7, 88/13; median age (range) 65 (40-75), 64 (34-75); stage IIIA/IIIB 33/66, 33/68; and PS of 0/1 46/53, 50/51, for the DP arm and for the MVP arm, respectively. The response rates for the DP arm and the MVP arm were 78.8% and 70.3%, respectively. The 1- and 2-year survival rates were 81.8% and 59.9% for the DP arm, and were 68.8% and 49.1% for the MVP arm, respectively. Median follow up time is 1.4 years in January 2006. Complete analysis will be fixed in July 2007.


CONCLUSIONS
The DP arm is exactly reproducing the response rate and survival of the phase II trial we have previously reported. The MVP arm seems to reveal better results than that we expected. Radiation dose and schedule might explain the difference because Furuse et al. splitted 56 Gy of TRT in the MVP arm whereas we did not split 60 Gy of TRT. No significant financial relationships to disclose.