Abstracts Not Presented/Chemotherapy: NSCLC 2 S279

as a 3-hour intravenous infusion and cisplatin at 75mg/m2 as an intravenous infusion on day 1 every 3 weeks.

Results: Twenty-seven patients were entered between Jan 2001 and Aug 2001 from 5 hospitals and 25 patients received chemotherapy. On an intent-to- treat basis, 9 patients (36%) achieved partial responses, 7 patients (28%) stable disease, and 5 patients (20%) progressed. The overall response rate was 36% (95% Cl, 17 to 55%). The median duration of response was 7.8 months (95% Cl, 6.6 to 9.0 months). The median time to progression was 7.4 months (95% Cl, 5.3 to 9.5 months), and median overall survival was 13.3 months (95% Cl, 10.8 to 15.9 months) for the intent-to-treat population. The major toxicity was hematologic with grade 3, 4 neutropenia in 10% (10/106) of total cycles. Non- hematologic toxicity was mild and grade 3 emesis was observed in 2 patients (8%). One patient experienced moderate degree hypersensitivity reaction.

Conclusions: The results suggest that combination of Genexol and cisplatin is an effective and well-tolerated regimen in patients with NSCLC.

cl 19 Clinical Effect of Cisplatin plus Gemcitabine versus Cisplatin plus Vinorelbine combination therapy for Patients with Stage Ii1 Non-small cell lung cancer

Hee Sun Park’, Jin Young Ahn’, Sung Soo Jung’, Ju Ock Kim’, Sun Young Kim3. 1 Dept. of Infernal Medicine, Chungnam Nafional University Hospital, Daejon, Korea; 2 Dept. of Internal medicine, Chungnam National University, Daejon, Korea; 3 Cancer Research Institute, Chungnam National University Hospital, Daejon, South Korea

Purpose: This study investigated to compare the clinical efficacy and toxicity of the cisplatin-gemcitabine with the cisplatin-vinorelbine combination therapy for the patients with stage Ill non-small cell lung cancer.

Patients and Methods: From September 1998 to December 2001, 76 pa- tients diagnosed as stage ill non-small cell lung. The Median age was 63 years (range, 42 to 77). Patients were received cisplatin at 75mg/m* on day 1 with gemcitabine at 1 ,OOOmg/ms (Group A) or vinorelbine 25mg/m’ (Group 8) on day 1 and 8. Cycle were repeated every 3 weeks. Response, toxicity and sur- vival were evaluated.

Results: Until December 2002, 32 patients had died and, 69 patients (39 Group A patients, 30 Group B patients) were analyzed. The median survival time was 70 weeks (Group A;57.9 weeks due to short term follow up, Group B; 92.6 weeks). The overall response rates were 56.5% (Group A: 64.1%, Group B: 46.7%, p>O.O5). The 1 -year survival rate was 57.9% (Group A: 56.4%, Group B: 60%). Grade 3/4 leukopenia or neutropenia were more frequent in the Group A than in the group B. But incidence of hematology and other nonhematologic toxicity did not differ significantly between the two groups.

Conclusions: The regimen of cisplatin-gemcitabine and cisplatin-vinorelbine for patients with stage Ill non-small cell lung cancer showed acceptable similar therapeutic response and tolerable toxicities.

q 20 Effect of Gemcitabine and Cisplatin Combination Chemotherapy in Stage III-IV Non-Small Cell Lung Cancer

Chi-Honq Kim, Hoon-Kyo Kim, So Hyang Song, Hong Joo Cho, Deok Gon Cho, Kyu Do Cho, Sung Hwan Kim, Myoung Im Ahn, Jin Young Yoo. Lung cancer center, St Vincent’s Hospifal, The Catholic University of Korea, Suwon, Republic of Korea

Purpose: To evaluate the response rates, toxicities, and survival rates in pa- tients with inoperable NSCLC (stage Ill and IV), who received gemcitabine and cisplatin combination chemotherapy every 3 weeks.

Material and Methods: This study included 30 patients with inopera- ble NSCLC (stage Ill and IV), who visited St. Vincent’s Hospital between June 2000 and June 2002. The chemotherapy regimen consisted of gemc- itabine (1250mg/m2 on days 1 and 8) and cisplatin (70mg/ms on day 1). The chemotherapy was administered every 3 weeks, A 25% reduction of the doses was applied in subsequent courses if there was grade 3-4 neutropenia.

Results: The median age was 57 (range 33-74) years and the male to female ratio was 2:l. One patient had stage Ilb, 1 stage Illa, 11 stage lllb and 17 stage IV. Eleven of the patients had undifferentiated NSCLC, IO squamous cell carcinoma, 8 adenocarcinoma and 1 large cell carcinoma. Four patients were not able to be evaluated due to stage (2), follow up loss (I), and expired within a month (1). of the 26 patients who were evaluated, IO patients had partial response, and overall response rate was 38.5%. Grade 3 neutropenia occurred in 16.7%, grade 4 neutropenia in 13.3%, grade 3-4 thrombocytopenia in 23.3%. The mean time to progression was 3.7 months (range 1 .O-13.6).

Conclusion: The combination of gemcitabine and cisplatin, in the dose and schedule employed in this study, showed an excellent response rate of 38.5%, but with significant bone marrow toxicities.

El 21 Chronic oral chemotherapy of advanced non-small cell bronchial carcinoma with etoposide and trofosphamide- A dose-finding phase l-pilot study of a new treatment principle

Carl-Johan H. Linden. Department of Respiratory Medicine, Lund, Sweden

Background: For advanced non-small cell lungcancer (NSCLC) the preferred therapy is intravenous chemotherapeutics at 2-4 weeks intervals.

Aim: In the current pilot study: patients were planned to receive a daily com- bination of oral chemotherapeutics; in contrary to conventional high dose in- termittent pulse therapy practise. The study aimed at defining an appropriate tolerable chronic dose level; to delineate the spectrum of side effects and tu- mour response rate as a base for further studies.

Methods: The planned starting dose was 25 mg/m* daily for etoposide and the same dose for trofosphamide. Hematologic parameters were checked once weekly and the dose of chemotherapy was individually determined for every treatment day in advancepatients: Nine patients with NSCLC stage IIIB-IV con- sented to participate in the study.

Results: One women experienced severe nausea and discontinued therapy after only six days. Another women developed generalised herpes zoster and therapy was discontinued after 53 days. Neither of these patients were evalu- able for response. Continuous oral chemotherapy was administered for 32; 27; 13; 12; 6; 5; 2; 1 months respectively. The mean weekly dose in mg/m” of body surface was 133f67 (SD) (median=147) for each of etoposide and trophos- phamide in a total of 447 weeks of treatment. Only one partial tumour response and five SD and 1 PD were recorded. The survival from start of chemother- apy was 36, 35; 25; 15; 8; 7; 7; 5 and 4 months; respectively. Treatment in- duced manageable hematologic toxicity but no period of septicemia or febrile neutropenia. One case of generalized herpes zoster occurred and required dis- continuation of therapy. Moderate alopecia and moderate nausea requiring oral antiemetics were also observed.

Conclusion: Combined oral chemotherapy is possible to administer for pro- longed periods with manageable toxicity in un outpatient basis. Albeit; the rate of tumour response was low l/9 it seems that this mode of treatment prolongs time to progression and retard tumour growth. This needs to be confirmed in a study of proper size.

cl 22 Gemcitabine and cisplatin in stage III-IV non-small cell lung cancer

lrena Spasova’, Eliska Illichova’, Vladimir Bartos”, Miloslav Marel’. ’ Pulmonary Department of the University Hospital in Prague - Mofol, Prague 5, Czech Republic; “Pulmonary Department of the University Hospifal in Hradec Kralove, Hradec Kralove, Czech Republic

Advanced non-small cell lung cancer (NSCLC) continues to be a difficult dis- ease to effectively treat. Gemcitabine (G) and cisplatin (P) have demonstrated activity in patients (pts) with NSCLC. We evaluated the activity, toxicity and sur- vival of a G-P regimen: G 1000 mg/ms days 1, 8 and P 75 mg/m* day 1 in every 3 weeks schedule. Pts were reevaluated after 2 courses, and treatment continued for 6 courses or until1 progression. Elrgrbrlrty criteria were advanced, unresectable NSCLC (stage IIIB and IV), measurable lesion, age 18-75 years, life expectancy more than 12 weeks, no prior chemotherapy and no curative radiotherapy, no cerebral metastasis. Between July 2000 and December 2001, 30 eligible pts were involved. M/F = 26/4, median age 62 years (46-77) stage IIIB/IV 19/l 1, initial PS 0:7, 1:19, 2:14. Toxicity: 154 cycles were administred, median 6 (range 4-6). Dose intensity for P was 100% and for G 99%. Hema- tological toxicity grade 3 or 4: neutropenia in 44% of cycles and 73% of pts, thrombocytopenia in 12% of cycles and 30% of pts, anemia in 9% of cycles and 27% of pts. No febrile neutropenia was discovered. Non-hematological toxicity grade 3 or 4 mainly consisted of nausea (17% of pts), asthenia (10% of pts) and weightloss (10% of pts). Partial response, stable disease and progression were found in 53%, 30% and 17% of pts, respectively. Median time of survival was 59 weeks.

Conclusion: The combination of G and P is an effective regimen in advanced NSCLC with partial response rate 53% and medial survival 59 weeks. The main hematological toxicities were neutropenia and thrombocytopenia whereas non- hematological toxicities were moderate.

III 23 Phase l/II study of cisplatin combined with weekly paclitaxel in patients with advanced non-small cell lung cancer

Kuniomi Matsuura’ , Naruo Yoshimura’ , Shinzoh Kudoh’ , Masashi Yamada’, Takashi Kawaguchi3, Yusuke Nakaoka“, Kazuto Hirata’, Junichi Yoshikawa’. ’ Osaka City University Medical School, Osaka, Japan; ’ Sumiyoshi Municipal Hospital, Osaka, Japan: 3 Kita Municipal Hospital, Osaka, Japan; 4 Osaka Japan Railway Hospital, Osaka, Japan

Purpose: To determine the maximum-tolerated dose (MTD) and the recom- mended dose (RD) of paclitaxel administered weekly with a fixed dose of cis-