S278 Abstracts Not Presented/Chemotherapy: NSCLC 2

q . 14 Phase II Study of Biweekly Vinorelbine and Cisplatin in Pabents with Stage IIIB or Stage IV Non- Small Cell Lung Cancer (NSCLC)

Chih-Huna Chen’, Wen-Jeng Chang’, Ying-Hwang Tsai’, Thomas C.Y. Tsao’ ’ First Division of Pulmonary & Critical Care Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan, Taipei, Taiwan; p Division of Hematology-Oncology, Chang Gung Memorial Hospital, Taipei, Taiwan, Taipei, Taiwan

Purpose: We conduct this study to evaluate the efficacy and toxicity of a bi- weekly regimen of Vinorelbine plus cisplatin as first-line chemotherapy in treat- ment for patients with stage IllB or stage IV non-small cell lung cancer (NSCLC).

Materials and Methods: Forty-three patients with NSCLC, who met the se- lection criteria from April 2001 to June 2002, were enrolled. All of them were confirmed by histology and in an advanced stage, i.e., stage IIIB with pleural effusion, or stage IV. Their performance status ranged from 0 to 2. Vinorelbine at a doe of 30,35 mg/ms and cisplatin at a dose of 50 mg/m’ were given to patients every two weeks.

Results: Fourteen patients with stage IIIB and 29 patients with stage IV NSCLC had been enrolled in this study. There were 27 males and 16 females. of the 43 assessable patients, 12 achieved a PR. The overall response was 27.9%. The median time to disease progression was 4.33 months (95% Cl 2.98 to 5.68 months). The median survival was 9.44 months (95% Cl 7.14 to 11.74 months). The major hematological toxicity was neutropenia. Fifteen (34.9%) patients developed grade 3/4 neutropenia. Five patients (11.6%) de- veloped grade 3/4 anemia. One patients (11.8%) developed grade 3/4 throm- bocytopenia. Non-hematologic toxicity included grade 3/4 nausea and vomiting in 8 patients (18.6%); grade 3/4 neuropathy in 2 patients; and grade 3 renal toxicity in one patient. There was no hepatic toxicity. Three patients developed neutropenic fever and one of them died from sepsis.

Conclusion: The biweekly combination of vinorelbine and cisplatin appears to be active and well tolerated as first line regimen in treatment for patients with advanced NSCLC.

q 15 New therapeutic prospects in lung cancer: a phase II study Michele Della Vittoria Scarpati’ , Giovanni Vicidomini’ , Mario Santini’ , Giuseppina Della Vittoria Scarpati a, Vincenzo Giuseppe Di Crescenzo’, Vincenzo Parascandolo’ , Eugenio Di Lieto ‘, Vincenzo Pastore’. ’ Thoracic Surgery, Second University of Nap/es, ItalK Napoli, Italy; 2 Second University of Naples, ItalK Napoli, Italy

Purpose: To evaluate the efficacy and toxicity of the combination of gemc- itabine, topotecan, taxol, and cisplatin (or navelbine) in the treatment of patients with advanced lung cancer.

Patients and Methods: From July 1999 to December 2002 (the study is still open) we treated 46 patients, 35 NSCLC and 11 SCLC, 43 males and 3 females, mean age: 64 years, P.S. 52 ECOG. of 35 NSCLC patients, 6 re- ceived prior chemotherapy. of 11 SCLC patients, 1 received prior chemo- and radiotherapy, 1 prior chemotherapy alone. Patients were treated by the foflowing regimen: gemcitabine 1000 mglm* i.v. by 60 mins, days 1, 8, 15; topotecan 3 mg/m* Iv. by 20 mins, day 1; taxol 135 mg/mz i.v. by 60 mins, following stan- dard premeditation; cisplatin 60 mg/ms i.v. by 30 mins; day 15. From May 2002, cisplatin was substituted by navelbine 25 mg/m’ Iv. by 20 mins, day 15. Cycles were repeated 6 times, every 28 days.

Results: To date, 213 cycles have been administered; 30 patients have com- pleted the regimen; 4 patients are still in treatment. Toxicity: hematologic ef- fects, WHO grade I, in the 8 pre-treated patients; alopecia in 100% of patients; no other toxicity was observed.

Conclusion: We believe that this regimen, for its complete feasibility, safety and handiness (outpatients administration), and therapeutic efficacy may be used in the treatment of lung cancer (both small or non-small), at every stage and as salvage therapy.

0 16 A multicenter phase II study of Cisplatin-Vinorelbine sequenced by Gemcitabine-Vinorelbine in patlents with unresectable Non-Small-Cell Lung Cancer (NSCLC): preliminary results

Marios E. Froudarakis’, Fotis Vlastos’, George Patlakasa, lrini Lambiri’ , Nikos Tzanakis’ , Mary Klimathianaki’ , Demosthenes Bouros3, Antonis Rasidakis’, Nikos M. Siafakas’ ’ Department of Pulmonology Medical School, University of Crete, Greece, Heraklion, Greece; 2 Center of Respiratory Failure, Hospital Chest Diseases, Athens, Greece, Athens, Greece; 3 Department of PulmonologL: Medical School, University of Thrace, Greece, Alexandroupolis, Greece

Background: In patients with unresectable NSCLC, best results in response rate is achieved after 3-4 chemotherapy cycles, while platinum resistance is

a major cause of failure. Sequential chemotherapy is currently under investi- gation, as it offers an opportunity to increase drug diversity, while maintaining dose intensity. The combination cisplatin (CDDP)-vinorelbine (VNL) is well es- tablished and gemcitabine (GEM)-VNL is promising. The replacement of CDDP by GEM in a phase II trial might be beneficial in case of platinum-related resis- tance and toxicity.

Methods: Twenty-two patients with unresectable NSCLC (PS=O-I) have been accrued in a phase II study of 3 cycles of CDDP (lOOmg/mZ dl) ? VNL (30mg/m2 dl,8) followed by GEM (lOOOmg/mz dl,8) ? VNL (30mg/m2 dl,8). 13pts have metastatic disease (59%). Cycles are repeated every 3 weeks. At this time, 11 patients (50%) have completed the study and are assessable for response and toxicity.

Results: Five out of 11 patients (45.5%) have partial response (one radiologi- cally complete response, but positive endobronchial biopsy), 2 patients (18.2%) have stable disease and 4 patients (36.3%) progressed during the study. Tox- icity is related to combination: significant nausea and vomiting is observed for CDDP-VNL (p<O.OOl), while myelosuppression for GEM-VNL (~~0.05). Other side effects, are rare and/or mild. At this time, toxicity has low impact on dose intensity, number of cycles and time of treatment.

Conclusion: Although the study is on going, we observe differences in toxi- city between the two combinations and, so far, acceptable response rate.

q 17 Phase II trial of Gemcitabine Plus Cisplatin in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: Two Year Follow-Up Result

Jeonq-Seon Rvu’, Se-Kyu Kim*, Young-Chul Kima, Jae-Yong Park4, Eun-Taik Jung5, Maan-Hong Jung”, Sun-Young Kim’. ‘Korean Lung Cancer Study Group, Incheon, South Korea; ’ Korean Lung Cancer Study Group, Seoul, South Korea; 3 Korean Lung Cancer Study Group, KwangJu, South Korea; 4 Korean Lung Cancer Study Group, TaeGu, South Korea; s Korean Lung Cancer Study Group, IckSan, South Korea; 6 Korean Lung Cancer Study Group, Susan, South Korea; 7Korean Lung Cancer Study Group, TaeJeon, South Korea

Purpose: As one of the third generation chemotherapeutic agents, gemcitabine is widely used in combination with cisplatin in the treatment of advanced non- small-cell lung cancer (NSCLC). In this study, we evaluated the efficacy, tol- erance, and survival of this combination in patients with locally advanced and metastatic NSCLC.

Patients and Methods: Patients received gemcitabine 1200 mg/m” on days 1 and 8, cisplatin 75 mg/ma on day 1 of a 21 -day cycle, for a maximum of nine cycles.

Results: Between January 2000 and September 2002, 143 untreated NSCLC patients were enrolled; 25(17.5%) had stage IIIA, 58(39.2%) had stage IIIB, and 62(43.4%) had stage IV diseases. Sixty-one percent of patients had a performance status (PS) of 0 or 1, The median number of cycles administered was 4(range, two to nine cycles). Grade three or four hematologic toxicities were noted in 80 patients (42.2%) during the chemotherapy, but there was no treatment related death. Non-hematologic toxicities more than grade three were observed in 19 patients (13.3%). Thirty-six patients received sequential radia- tion therapy according to the clinical policy of the department. Overall median survival was 13.1 months, and two-year survival was 24.1% (20.3 months for stage IIIA, 12.8 months for stage 1118, 12.0 months for stage IV; p=O.8318). Me- dian survival was 14.7 months for patients with a PS of 0 or 1 and 9.4 months for patients with a PS of 2(p=O.O017). The overall response rate was 53.8% among the evaluated 131 patients after two cycles of chemotherapy. The me- dian survival time of the responders was significantly longer than that of the non-responders (16.3 months vs. 10.1 months, p=O.O008).

Conclusions: A three weekly gemcitabine/cisplatin regimen was relatively well tolerated, with an acceptable response rate and a reasonable median sur- vival in locally advanced or metastatic NSCLC.

q : 18 A Mulh-Center, Phase II Clinical Trial of Genexol(Paclitaxel) and Crsplatin in Patients with Non-Small Cell Lung Cancer

Hoon-Kvo Kim’, Se-Hoon Lee”, Keunchil Park3, Cheolwon Suh4, Jun-Suk Kims, Young-Hyuck lms, Sang-We Kim4, Dae-Seog Heo2, Yung-Jue Bang’, Noe Kyeong Kim*. ‘St. Vincent’s Hospital, The Catholic University of Korea, Suwon, Korea; 2 Seoul National University Colege of Medicine, Seoul, Korea; 3 Samsung Medical Center, Seoul, Korea; 4 Asan Medical Center, Seoul, Korea; 5 Korea University Guro Hospital, Seoul, Korea

Purpose: Paclitaxel and cisplatin is an effective and safe regimen for advanced non-small cell lung cancer (NSCLC). We conducted a multi-center, phase II trial to evaluate the efficacy and safety of Genexol (paclitaxel) and cisplatin in patients with NSCLC.

Materials and Methods: The chemotherapy-naive patients having histologi- cally confirmed NSCLC were enrolled. Genexol was administered at 175mglms