A Phase II Study of Paclitaxel and Cisplatin Combination Chemotherapy in Advanced Non-small-cell Lung Cancer.

Jung Ae Lee, Keun Seok Lee, Jin Seok Ahn, Jae Ho Byun, Hun Ho Song, Dae Young Zang, Young Iee Park, Young Suk Park, Eun Kyung Mo, Dong Kyu Kim, Myung Goo Lee, In Gyu Hyun, Ki Suck Jung, Soo Mee Bang, Gye Young Park, Jeong Woong Park, Eun Kyung Cho, Seong Hwan Jeong, Dong Bok Shin, Jae Hoon Lee

Paclitaxel and cisplatin, active drugs in the treatment of non-small-cell lung cancer (NSCLC), have been found to be synergistic and less myelotoxic in combination when the paclitaxel is given 24 hr prior to the cisplatin. Their antitumor activity and toxicity in patients with advanced NSCLC has been evaluated herein. Seventy-four chemonaive patients, with advanced NSCLC, were enrolled. Paclitaxel, 175 mg/m2, was administered on day 1, followed 24 hr later by cisplatin, 75 mg/m2, on day 2. The overall response rate, median time to progression and median survival time were 51%, 7.1 months (95% confidence interval (CI), 5.5~8.7 months) and 13.7 months (95% CI, 11.3~16.1 months), respectively. There were significant differences in the overall survival rates in relation to stage and the ECOG performance status(PS). The toxicity was mainly nonhematological. Grade > or =3 neuropathy occurred in 2 (3%) patients, myalgia in 3 (4%), and bone pain in 3 (4%). The hematological toxicity was mild, and no grade 3 or 4 neutropenia was observed. The combination of paclitaxel and cisplatin is an effective and tolerable treatment regimen for advanced NSCLC during first line chemotherapy. The main toxicity was nonhematological, such as peripheral neuropathy, myalgia and bone pain, whereas the hematological toxicity itself was mild.