404

405

PHASE II TRIALS IN SMALL CELL LUNG CARCINOMA (SCLC) 1970-1990. THE CASE FOR ENTERING PRMOUSLY TREATED PATIENTS. SC Grant, RJ Gralla,

MG Kris, J Orazem, EA Cohen. Memorial Sloan-Kettering Cancer Center, New York, NY 8 Oschner Clinic, New Orleans, LA, USA

We evaluated all 141 single-agent phase II studies in SCLC published from 1970-l 990 to determine: 1) if a case couM be made for entering previously treated patients, 2) the adequacy of trials, and 3) if study designs were appropriate for evaluating new agents. Prior treatment status was reported in 16.3%, disease stage in 41 .l%, performance status in 73.6%, age in 72.3%, sex in 56% and weight bss in 3.5%. 36 agents have not been adequately evaluated in SCLC. From 1 to 116 patients with SCLC were entered into individual trials. 59 trials (41.8%) entered c 14 patients and 21 (14.9%) had > than 29 eveluable patients. 65 Trials reported a 0% response rate of which 37 entered < 14 patients. 11 drugs had activity L 20% in adequate trials: ACNU, carboplatin, cisplatin, cycbphosphamtiq doxorubicin, epirubicin, hexamethylmeiamine, VP-l 6, VM-26, vincristine and vindesine. Ail agents currently considered acthre would have been Mentifisd in adequate triils entering previously treated patier@, had a response rate L 10% been taken as evidence of activii and thii will allow identification of non-cross resistant agents. We conclude 1) Important patient data is frequently lacking. 2) Typicalb too few or too many patients are entered. 3) Previously treated patients are acceptable candidates for phase II trii in SCLC 4) We propose guidelines for phase II trials In SCLC based on a two- stagesequentialstudy designenteringpreviouslytreatedpatients. Supported by HHS grant CA-05626 and NIH grant CA-091 49-l 5.

PHASE I STUDY OF HIGH DOSE CISPLATIN. IFOSFAHIDE AND VP-16 IVIPP‘) IN ADVANCED NON-SMALL CELL LUNG CANCER (NSCLCI. PEREZ EA. SOWRAY PC. FORY LW. GANDARA DR. NORTHERN CALIFORNIA ONCOLOGY GROUP. BELMONT. CA AND UC DAVIS/ VAHC MARTINEZ. CA 94553.

To test feasibility. 15 patients Ipts1 with advanced NSCLC (staqe III/IV: 5/10) received cimlatin iOOmq/m2 IV dl & d8 in hvoertonic saline. ifosfamide 1.0-1.2 qm/m2 IV dl-3 and VP-16 60-75 mq/m2 IV dl-3.reoeated q 28 days. All pts. were assessable for toxicity and resoonse. Male/Female: 13/2. Median age:59 147-72). Median KPS: 90 (70- 1001. Median number of cvcles delivered : 2 lranqe i-4). Hematologic toxicity (>Gr 1111 was substantial: WBC: 10 ots. olts: 7 ots. Hqb: 7 ots. Renal: 0 ots. Neuro: 0 ots. ReSDOnSe: CR: 2/15 113%). PR: 3/15 120x1. CR+PR: 5/15 (33%). Time to progression : 23 weeks. Median survival time: 66 weeks. We conclude that althouqh this reqimen demonstrates activitv. hematoloqic toxicitv orecludes further evaluation.

406

RANDOMIZED TRIAL OF CISPLATIN(CDDP) PLUS IFOSFA- MIOECIFM) VERSUS CDDP PLUS VINDESINE(VDS) FOR NON SMALi CEiL LUNG CANCER(NSCLC): T.Nakabay&hil,H.

Miyamoto2.T.Shimizu3,T.Fujikane3,S.Yasuda4,H.Akita2,E. Sakai3,S.Onoderas,U.Ohsaki6 and Y.Kawakami2 lSapporo National Hospital.2Hokkaido University.3National Sana- torium Dohoku Hospital,kHakodate National Hospital, sAsahikawa Medical College.~Iwamizawa Rosai Hospital, 1Sapporo. 003, Japan.

Between Z/87 and 10/89, 83 patients (pts) with previously untreated NSCLC were assigned at random to receive either the PI regimen(CDOP 80mg/m2 dl and IFM 2g/m2 d1.2.3. q 3-4 wks) or the PV regimen(CDDP 80mg/ m2 dl and VDS 3mg/mz d1.8.15. q 3-4 wks). Three pts(2 PI regimen, 1 PV regimen) were ineligible for the study and 13 pts(7 PI regimen, 6 PV regimen) did not complete it. 33 PI regimen pts and 34 PV regimen pts completed 2 or more cycles of the treatment and were evaluated. Patient characteristics were almost identi- cal in both groups in terms of sex. age, pathological types, stage, performance status and number of chemo- therapy cycles. For the PI regimen, there were 1 C.R. and 6 P.R. and the response rate was 21.2%(7/33). In the PV regimen, there were 11 P.R. and the response rate was 32.4%(11/34). The median survival time(MST) for PI regimen was 29 weeks(ranye 12-156 wks) and for PV regimen 40 weeks(range 8-138 wks). The difference of the survival curves for the 2 regimens was not sta- tistically significant. Toxicities on the 2 regimens were similar except for greater leukopenia and one treatment related death due to renal toxicity on PI regimen. These results suggest that PI regimen is inferior to PV regimen in the treatment of NSCLC.