129

479

PHASE II INTENSIVE WEEKLY TREATMENT SCIIRDULE WfllI SIX DRUGS FOR RXTRNSIVR

DISEASE SMALL CRLL LUNG CANCER (SCLC). Galen L. Wampler and Diane Alt for the Mid-Atlantic Oncology Program. Richmond, VA and Chapel EIlll, NC USA.

Using a weekly treatment program that is about 50% more dose intense than standard regimens for SCLC 31 patients have been treated and 29 are evaluable. Drugs used were etoposide 50 mgMx3 and cisplatin 50 mgM’(P) on wk 1, vincristine 1.4 rnfl, max 2 mg(0) and P on wk 2, doxorubicin 50 mg/lvP and cyclophosphamide 350 mgM on wk 3 and methotrexate 100 mgM (with leucovorin) and 0 on wk 4. Three cycles were given for a total of 12 weeks treatment. Severe or greater toxicities were leukopenia 626, anemia 55% thrombocytopenia 24% mucositis 14% infection 10% and neurologic 10%. One toxic death was reported. There were 8 complete responses in the indicator lesion but only 4 documented in all sites of known disease. There were 8 partial responses, 6 stable disease and 6 progression. The toxic death patient is excluded from response analysis. Survival results are currently premature. This regimen can be given safely in the cooperative group setting but unless there is improvement in two year survival the results are not particularly exciting.

Supported by a merit review Veterans Administration grant

481

SMALL CELL LUNG CANCER (SCLCI : PREBIMINARY RESULTS OF A RANDOMIZED CLINICAL TRIAL ON

CYTOXAN- DOXORUBICIN- ETOPOSIDE (CDE) CHEMOTHERAPY VS CIS-PLATIN- CDE (P-CDE) CHEMOTHERAPY (CT) B. LEBEAU, Cl. CHASTANG for the “Petites Cellules” Group (04 PC 88 protocol). Service de Pneumologie. H8pital St Antoine, 184, rue du Faubourg St-Antoine, 75571 Paris Cedex 12, France. From May 1, 1988 to April 30, 1991, 375 pts with SCLC entered a multicenter (35 centers) randomized study. Inclusion will be closed at the end of 1991. Patients were randomized to receive a CDE CT (Cytoxan 1 g/m2 IV Jl. Adriamycin 45 mg/m* IV Jl, Etoposide 150 mg/mz IV 51-2) or a P-CDE CT (CDE + Cis-platin 100 mg/m* IV Jl). In both Included pts il

roups CT was given every four weeks. ad predominantly disseminated forms of

SCLC (305 vs 70 limited forms as the best cases were preferently included in a trial assessing thoracic radiotherapy). In 290 pts for whom the follow-up enabled assessment of response and toxicity we observed the following results : Number of*pts CR PR NR Response not Toxic deaths

evaluable P CDE CDE

144 40 59 19 26 16 I46 21 56 61 8 3

In the pts included before October 31. 1990 we observed that during the first month of treatment 20 pts died in the P-CDE grou and in contrast that pts w o deceased after more than R vs 12 in the CDE group one year of survival are 22 in the P-CDE group against 13 alone in the CDE group. In these patients with poor efficacy R rognostic factors P-CDE has better

t an CDE but so induced a high medullary toxicity. For such a CT, these pts may benefit of medullary growing factors.

SUBCUTANEOUS HEPARIN TREATMENT INCREASES CDMPLETE RESPONSE RATE AND OVERALL SURVIVAL IN

SMAL\E;;;b LUNCGl CANCEsCERf;;C f . B. “Petites Cellule’s” Group (0:

for the de Pneumologie. Hbpital St Antoine, ZP’Z Faubourg St-Antoine, 75571 Paris C&iex 12, F;ante. From October 1, 1985 to April 30, 1988, 434 pts with SCLC entered a multicenter t2? centers) randomized clinical trita;ou;heyAyyived e;Goreroy ~h~e~gulant treatment subcutaneous 9, -

daily eparin injecTions during five weeks at

curative 2;s~~ cyorolled by blood coagulation tests (group chemotherapy, randomized &aetween CCNU Cytoxan

patients were Adriam tin and

at every course vs an alternatinb chemot &z VP16

rap y tC+C+A alterned with CDDP, vindesine, VP161. Comp ete and partial responders (CR + PR) received 8 courses of their regimen and then could be randomized for thoracic radiotherapy. receive anticoagulant

Some pts needed or could not randomized for heparin : “9 4oon;:s (26852 1 Piz~eed”tsl w::s 75 extensive, e,) in the group AC+ versus 142’pt; (58 1 and 84 e) in the group AC-. At the reference date of January 1. 1991 one Results are summarized n this table : P

atient was lost to follow-up. Survival

CR rate Median 1 vr 2 vr 3 vr still - - _ alive

Group AC+ 37 % ;;i i 43; ; ‘I8 ; 9 % 10 FKzup AC--

23 % 6% 4 differ&:erank jz:&r of

pointed out a significant I!

roup AC+ for overal 1 survival tp=O.OlI and for benefit was

R rate (p=O.O04). This mainly observed in limited disease

( -0.03) but not in extensive disease (p-0.31). No bleeding or thrombopenia was treatment. Duration and

related to heparin t pe. ar

of treatment deserves further stu

anticoagulant les.

SMALL CELL LUNG CAN;;fh, RANDOMIZED

ANTIAGiEGANT THERAPY LOI+; TEARSnpI~E&ULTS OF

vs NO

B. LEBEAU, Cl. CHASTANG, F. CAPRON for the “Petites Cellules” Group (01 PC 83 protocol). Service de Pneumologie. Hbpital St Antoine, 184. rue du Faubourg St-Antoine, 75571 Paris Cedex 12. France. From January 1, 1983 to September 30, 1985. 320 patients with . small cell lung cancer entered . a mult;g;et;ltar clinical trial (P;C;;ntegrgsI all :eceiving

tyclo~hosp~am~?t~~pyIV, Adriamycinem!/5mmg/i$oIV and V 16 150 mg/m’ IV, day one). Patients in complete remission after 6 courses were randomized to receive or not six more courses. Initially, patients were randomized to receive either aspirin tlg/day during i; months) tn =. 163 patients) or no antiagregant = 157 patients). Seventeen patients were subsequently excluded for not fulfilling pathological criteria. At the reference date of January 1. 1991, no patient was lost to follow-up. Results are summarized in this table : Survival Median 1 year 2 year 3 year 5 year Still

alive

In contrast with Zacharski who demonstrated the benefit of warfarin and with our following study for heparin (02 PC 85 protocol) we did not point out an benefit tp = 0.90) from aspirin in SCLC treated wit K a conventional chemotherapy. The major prognostic factor was initial extension : median survival was estimated at 369 days in the 140 localized forms and at 224 days in the 163 disseminated forms : p < 0.0001).