B non-small cell lung cancer

Poster Session 2/Combined Modality Methods: Patients with marginally resectable stage IllB NSCLC, an age of younger than 70 years, a performance status of 0 or 1 and a good organ function were eligible. UFT (400 mg/m’) was administered orally on days 1 through 14 and 22 through 35 and cisplatin (80 mg/m’) was injected intravenously on days 8 and 29. Radiotherapy with a total dose of 40 Gy was delivered in 20 fractions on days 1 through 26. A surgical resection was performed from 3 to 6 weeks after completing the induction treatment. Results: Twenty-seven patients were entered into the phase II trial, consisting of 18 males and nine females with a median age of 56 years ranging from 36 to 69. Clinical T4 and N3 were observed in 22 and 7 patients, respectively. Twenty-five (93%) achieved a partial response. The most frequently observed adverse event was grade 3 leukopenia in 26%. Out of 25 patients who underwent a thoracotomy, 22 had a tumor resection. In all 22 patients, a complex resection including a resection of the superior vena cava, carina, vertebrae and so on was required. Operative morbidity and mortality rates were 36% and 4%, respectively. The calculated 1 and 3-year survival rates of all 27 patients were 78% and 58%, respectively. Conclusions: Chemotherapy using UFT plus cisplatin and concurrent radiotherapy as induction treatment and a surgical resection for patients with marginally resectable stage IIIB NSCLC is feasible and promising. However, it is difficult to conduct multiinstitutional trials even for selected stage IIIB disease since a complex resection in almost all patients is necessary. P 249 El

lntrapleural cisplatin treatment for lung cancer with positive pleural lavage cytology or malignant effusion

Masashi Muraoka’, Shinji Akamine’ , Tsutomu Tagawa’ , Takeshi Nagayasu’ , Masao lnoue’ , Takatomo Yamayoshi ’ , Keitaro Matsumoto’ , Yutaka Tagawa’, Tadayuki Oka’. ’ Division of Surgical Oncology Department of 7ianslational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; 2 Nagaski Unversity School of Health Sciences, Nagasaki, Japan

Background and Objective: The prognoses of patients who have primary lung cancer with positive pleural lavage cytology (PLC) or malignant effusion are poor. We evaluate the complications and survival of the modified intrapleural cisplatin treatment for these patients. Patients and Methods: Pleural cavity aspirations were evaluated by the cytologist after 50 ml of physiologic saline solution was instilled into the pleural space if any pleural effusion was absent. Intrapleural cisplatin treatment was performed for 20 patients (10 male, IO female, mean age 64.8 years); 5 patients had advanced lung cancers with malignant effusion and 15 patients with positive pleural lavage cytology. All of these patients were pathologically diagnosed as non-small cell lung cancers. After pulmonary resection, the pleural cavity was filled with lOOmg/body of cisplatin with a normal saline solution for 30 minutes. We did not perform the treatment on eight patients in the same situation (control group) because of their advanced age (2), renal dysfunction (2), or no informed consents (4). Morbidity and mortality after the treatment and the survival were analyzed. Results: One patient had p-stage IA disease, 6 had p-stage 18, 6 had pstage IIIA, 5 had p-stage 1118,and 2 had p-stage IV disease. The chest tube duration after the treatment were significantly prolonged in the treatment group compared with the control group (6.2 f 3.5 vs. 2.8 i 2.6 days). Eleven patients developed some complications, all of that except 1 bronchial fistula were not serious, resulting in a morbidity rate of 55%. One patient died due to respiratory failure within 30 days, resulting in a mortality rate of 5.0%. We experienced recurrences due to carcinomatous pleuritis after the treatment in two patients (10%). The median survival time (MST) of the treatment group was 32.0 f 2.4 months and the 3-year, 5-year survival rate was 40.7% and 13.6%, respectively. Conclusions: We were able to perform the modified intrapleural cisplatin treatment for lung cancer patients with positive pleural lavage cytology or maKaplan-Weieiti % I -

Therapy: NSCLC

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I P 250

Combined modality treatment in stage IIIA/B non-small cell lung cancer

K.W. Maas’, H.A. van Swiete$, V. van Munnink2, P. Hofman3, F.M.N.H. Schramel’. ’ St. Antonius ziekenhuis, Nieuwegein, The Netherlands; 2 St. Anfonius Hospital, Nieuwegein, The Netherlands; 3 University Hospital, Utrecht, The Netherlands

Background: Multimodality treatment has become the standard of care for patients with non-small cell lung cancer stage Ill, the main goal of neoadjuvant chemotherapy is to eradicate micro-metastases, mediastinal lymph node metastases and to diminish the tumor. Platinum-based combinations has shown significant activity in advanced NSCLC with high response rates up to 70% in several phase II studies. Surgery and or radiotherapy will result in a prolonged survival after neo-adjuvant chemotherapy. Methods: A retrospective one center trial of neo-adjuvant chemotherapy (gemcitabine/cisplatin) followed by surgery and/or radiotherapy in 128 patients with stage Ill NSCLC. Endpoints were toxicity, response rate, complete resectability and survival. The mean follow-up time was 19.2 months (1.9-74 months). Results: The group consisted of 128 evaluable patients. Stage IIIA was diagnosed in 64 of the patients, the rest was diagnosed with 1118.The mean age was 60.6 years. 76% of the patients were male. Response rate after neo-adjuvant chemotherapy was 69%. Resection was performed in 42 patients (33%), 18 patients with NSCLC stage IIIA and 24 patients with NSCLC stage 1118,in nineteen patients resection proved to be radical (45%). No difference in survival after surgery was observed in stage IIIB patients compaired to IIIA. Major complications occurred in ten patients (fistula, empyema, hemorrhage, infection). Ninety-four patients underwent radiotherapy of which 36 were diagnosed with stable/progressive disease, 35 patients with partial/complete response and 23 patients postoperative. Median survival for patients treated with curative surgery was 25.6 months, for patients treated with curative radiotherapy 17.8 months, for patients treated with surgery and postoperative radiotherapy 19.3 months and for palliative radiotherapy 9.9 months (p=O.O25). Conclusion: Curative surgery can be performed in 45% (19/42) of the responders resulting in a prolonged survival. Surgery as part of combined modality treatment is feasible in NSCLC stage IIIA/IIIB and results in the best overall survival. Patients with stage IIIB NSCLC should be treated similar as stage IIIA. Gemcitabine/cisplatin proved to be an effective combination with a response rate of 69%. 1 P-251 1 Randomized Phase II Trial of Weekly Carboplatin/Paclitaxel (C/P) versus Every-3-Week C/P in Advanced Non-small Cell Lung Cancer (NSCLC): A Pure Schedule Trial Mark A. Socinski’ , Thomas A. Hensing’, Miluska Escudero’ , Maureen Tynan’ , Maria Baggstrom’ , Anastasia Ivanova’, J.H. Li’ , Kamal Bakri’. ’ Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hi//, USA; ’ Hem/One Assoc of Fayettevile, Fayettevile, USA Although C/P remains the most commonly used first-line regimen in the U.S., the optimal schedule of P in this regimen has not yet been defined. We are currently conducting a randomized phase II trial evaluating a pure schedule question. Pts are randomized to either carboplatin AUC 6 and paclitaxel 225 mg/m* every 3 weeks for 4 cycles (Arm A) or carboplatin AUC 6 every 3 weeks x 4 and paclitaxel 75mg/mz/week x 12. Cumulative doses of each agent are identical on both arms. The endpoints of interest include toxicity, objective response, quality of life, median, and l-year survival. Thus far, 77 pts have been