154

571

PREOPERATIVE CHEMOTHERAPY IN NON-SMALL CELL LUNG CANCER STAGES I, II AND IIIA. R. Chapman, D. Lehman, J. Lewis, P. Kvale, M. Mettetal.

Henry Ford Hospital, Detroit, MI 48202. Long term survival in surgically resected patients

with advanced (NSCLC) at best, has been poor. In this study, we have looked at 58 patients; Stage I (T only) (n=15) Stage II (n-11), and Stage IIIA (n=jZ) and entered them into this trial. Objectives of the trial were to determine: 1) complete resectability rate, 2) safety of surgery after chemotherapy, and 3) disease free an overall survival rates. Cisplatin ~I$P~,~~ZO mg/m 4 day 1 and 29) and vinblastine (VLB)

m days 1,2,15,16,29,30) were given preopera- tively. Patient's were then assessed for response with responders receiving two identical cycles post- operatively. 44 patients (76%) have been completely resected. Pre-operative response rate to chemotherapy is 60%. Median overall and disease free survivals to date are as follows: Stage I-21.3 and 15.6 months, Stage 11-26.9 and 22.8 months, Stage 111-21.6 and 12.9 months. Median survival for the study has yet to be reached. Of patients who have undergone surgery, there have been two post-operative deaths (massive intracerebral hemorrhage and ARDS), and one empyema. There have been no chemotherapy deaths, however, one patient experienced gram negative shock while neutro- penic which resolved with appropriate antibiotics. We conclude: 1) response rates from DDP and VLB are en- couraging, 2) surgery can safely be performed follow- ing neoadjuvant chemotherapy, 3) resection rates are high, 4) survival appears encouraging, and 5) random- ized trials are needed for this approach.

573

PATHOLOQIC COMPLETE RESPONSES @CR) IN ADVANCED NON-SMALL CEU LUNG CANCER (NSCLC) FOUO~~N~ PREOPERA~~E CHEMOTHERAW. KMW Piiters, MG Krts,

RJ Gralla, MB Zaman, RT Heelan, N Martini. Memorial Sioan- Kettering Cancer Center, New York, NY10021, USA.

WehaveidentfiedandrevIewedthecoursesof13patiente achievingpCRfollowingpreoperativechemotherapytodetermine: 1) the incidence of pCR with MVP chemotherapy, 2) if pCR influences survival, 3) predisposing factors for pCR. 9 were among 73 (12%) entered on a preoperative chemotherapy program for pts with clinically apparent mediastinal spread (N2). All received 2-7 chemotherapy cycles (median-9 including: cisplatin 120 mg/m2 + vindesine or vinblastine + mitomycin (n=lO). Pt characteristics: 8 men; median KPS-80%; 31%-f serum LDH; 4 adenocarcinoma, 5 epidermoid, 4 large cell. 12 were stage IIIA 8 1 stage IV. After chemotherapy, all had a major objective responses, 8 had CR. 1 underwent pneumonectomy, 5 had bbectomles, 7 other procedures. Postoperatively, 7 received additional chemotherapy and 2 mediastinal irradiation. Median follow-up is 72 mos (range 8.5-91.4 mos). Kaplan-Meier survfval plots indicate: median survival not reached, 1 yr-92%, 3 yr-83%, 5 yr-74%. 4 pts have recurred: 1 locally (34.3 mos), 2 in brain only (11.4 B 55.3 mos), and 1 systemically (7.1 mos). 3 relapsed pts have died; 1 is alive at 83.8 mos. At least 8 of the 13 have returned to work. We conclude: 1) Pathologic complete response is seen in ~12% of advanced NSCLC pts treated wtth preoperative MVP chemotherapy; 2) pCR was seen only in pts with major responses to chemotherapy; 3) pCR predicts excellent survival and functional level. Supported by HHS CA-05828.

572

CONCURRENT DAILY LOW-DOSE CISPLATIN (LDCP) PLUS CHEST IBBADIATION (RT) FOLLOWED BY

STANDARD DOSE CISPLATIN (SDCP) IN LOCALLY ADVANCED NON-SHALL CELL LUNG CANCER (NSCLC): PRELIMINARY RESULTS OF A PHASE II STUDY. Hazuka MB, Bunn PA, Crowley J, Livingston RB. Univ. of Colorado, Denver, CO, Southwest Oncology Group (SWOG) Statistical Ctr. and Univ. of Washington, Seattle, WA, USA.

In a European randomized study, concurrent daily LDCP plus split-course RT was shown to be superior to split-course RT alone (IJROBP 19:967-972; 1990). Since continuous high-dose RT provides better locoregional tumor control than split-course RT, the SWOG choose to study daily LDCP at 5 rag/M2 with continuous RT (61 Gy/6.5 wks) followed by 3 28 day cycles of SDCP (50mg/MZday 1,8) in a non-randomized, phase II trial. Between 4/89 and 5/91, 65 pts primarily with stage IIIa (39%) and IIIb (51%) NSCLC were registered. Pt characteristics were: median age 64 (range 39-74), male/female 81%/19%, PS O-1/2 88%/12%. Response rates to daily LDCP/RT and SDCP (n-28) were: CR-4%; PR-25%; NR-32%; INC-14%. The median survival for stage IIIa pts exceeds 12 mo and is 10 mo for IIIb pts. Treatment was generally well tolerated; gr 3 leukopenia (17%) and esophagitis (15%) were the most common severe toxicities. We conclude that the concurrent administration of daily LDCP plus continuous high-dose RT is feasible in a cooperative group setting. Response rates and survival will be updated.

574

Intensive Chemotherapy(CT) Followed by Chest Irradiation(RT) in Patients with Limited Small Cell Lung Cancer(LSCLC)

Ikuro KIMURA, Taisuke OHNOSHI, Shunkichi HIRAKI, Hiroshi IJEOKA, Yoshihiko SEGAWA and Masahiro TABATA Department of Medicine, Okayama University Medical School, Okayama 700, Japan

Patients with LSCLC receiving CT and delayed chest RT between 1986 and 1991 were evaluated for tumor response, toxicity and survival. As a pilot study, the initial 15 patients received a CAV-PVP hybrid(CAV on day 1 and PVP on day 8)regimen up to 5 to 6 cycles, and then chest RT of 50Gy(2Gyx25/5wks). The succeeding 48 patients were randomly allocated to receive either the hybrid regimen or a sequential CAV-PVP(3 CAVs followed by 3 PVPs) regimen. In this setting, chest RT was delivered at the same dose when a patient was believed to achieve a maximal tumor response. All the responding patients received PC1 of 30Gy(2Gyx15/3wks). The CT regimens were equally effective; only one patient failed to respond to the hybrid regimen. Of 55 patients who were fully evaluated for tumor response after chest RT, 35(64%) achieved CR and 19(35%) achieved PR, for an overall response rate of 98%. The projected median survival time was 19.7 months and the projected 2-year survival rate was 43.1%. Toxicity by chest RT was extremely mild; no patient required hospitalization for toxicity. This type of chest RT appears effective for LSCLC when a preceding CT is definitely active.