122

for 2 to 3 courses2at standard dosage (SD) (cis~latin 60 mg/m dl + adri~mycine 45

mg/m dl + etoposide 120 mg/m--dl, 2,3); followed by LI (2 to 3 times SD) with au- tologous bone marrow transplantation (ABMT). Severe mucositis was the limiting extra- hematological toxicity.

2) AVE regimen: AVE was given for 3 cour- ses at SD (adriam~cin 45 mg/m- dl + cyc~o- phosphamide 1 g/m- dl + etoposide 80 /m- dl, 2,3), followed by LI (3 x SD) with ABMT. Severe mucosistis prevented further dose escalation. ABMT was not necessary.

3) VE regimen: LI with VE (cyclophos- phamide 10g to 200 mg/kg + etoposide 750 to 3.5 g/m- administered over 48 hours with ABMT) was given after 3 courses of AVE or CAVE (AVE + cisplatin 60 mg/m~ dl) at SD. Severe cardiac failure appeared to be the limitant extrahemopoietic toxicity. The need for ABMT could not be clearly shown.

CAV AVE VE Number of patients ~ -nO-- I-6 CR before LI 5 3 3 CR before LI 6 3 8 Median duration of remission (months) 7 8 9

(range) (2-57+)(8-11)(3-36+) Median Survival 8.5 19 12 time (months) (range) (2-57+) (8-27)(3-36+) 3 year disease- 1 - 1 free survival

We conclude that additional complete re- sponses have been obtained with LI, howe- ver the duration of response and survival of the LI patients were poor.

EORTC 08828: Induction Versus Induction Plus Maintenance Chemotherapy (ct) In Small Cell Lung Cancer. Phase II Evalua- tion. Splinter I, T., McVie, J., Dalesio, O., Kirkpatrick, A., Burghouts, J., Postmus, P., Veenhof, C., Giaccone, G., Kho, G., Bakker, W., ten Velde, G., Vendrik, C., v. Zandwijk, N., Palmen, F., Rozendaal, K., v.d. Burgh, M., v. Breukelen, F., Rinaldi, M., Kleisbauer, J., Gracia, J., Wils., J., Miech, G., Festen, J. i. University Hospi- tal Dijkzigt, Rotterdam, The Netherlands.

In August 82 a randomized phase III trial was started to investigate the (dis- ease free) survival after 5 and 12 courses of ct. Study design: after registration pts were given 5 courses of ct and restaged. All pts with CR, PR or NC were stratified according to extent of disease, CR and PR or NC, symptomatic brain mts and randomized to follow-up or 7 courses of ct. All CR- pts received prophyl, brain irr. No other radiother, was given. Selection criteria: ECOG 0-3, age < 70 yrs, no previous treat- ment, no uncontrolled cardiac disease or infection. (Re)staging: phys. exam, bio-

chemistry, chest x-ray, CT-scan ultra-

sound, bone-marrow biopsy, bronchoscopy+biopsy,

radionuclide bone scan. Definition of LD: tumor limited to one hemithorax, contralateral hilar nodes, supraclavicular nodes both sides. CT-re -

2 gimen: cyclophos~hamide i000 mg/m daY21 , dox- or-~-6~icin 45 mg/m day i, Vpl6 i00 mg/m day i, 3,5. Assessment of response: according to WHO (1979). In addition CR-pts should have no ab- normalities at bronchoscopy. Results till ran- domization: 477 pts are registered. Overall re- sponse in 288 pts: CR 35%, PR 38,5%, NC 4,5%, PD 15%, early death in 28 pts (9,5%). Survival from registration XR=X-ravs: BR=bronchoscopy:

~ i . Rank s a a l . p ( O , 0 0 0 2 p ( O . O 0 2 ; ~ - XR+ %R+

~ o r a l l ~ ED ~ P ~ N C ~ BR+ BR- BR+

no. o f p ts 402 147 104 1 ;0 141 74 11 gO 41 med. surv . wks 43 60 45 60 45 55p ~800,0340 39

Concl.: CAvpl6 is effective in SCLC with a high response rate and very acceptable med. survival in a large group of pts. with hardly any selec- tion; bronchoscopy dose not seem to improve the restaging by radiological methods.

High Dose Teniposide (VM26) in The Treatment of Non-Small Cell Lung Cancer (NSCLC). Giaccone, G., Ferrati, P., Donadio, M., Calci- ati, A. Medical Oncology, Ospedale S. Giovanni A.S., 10123 Torino, Italy.

17 patients (pts) wi~h advanced NSCLC were given VM26 120-180 mg/m- on days i, 3 and 5, every 3 weeks, from October 1983 to December 1984.

All were males, median age 58 yrs (range 49- 66), median P.S. (ECOG) 1 (range 0-2), i0 squamous cell, 3 adenocarcinoma, 3 large cell, 1 poorly differentiated histology; 9 extensive disease, ii pretreated (i RT, 4 RT+CT, 3 CT, 2 surg+CT, 1 surg+RT+CT).

Overall 61 cycles were administered (mean 3.6 per patient, range 1-7). Among 17 evaluab- le patients 1 partial response (6.2%), 9 no change, and 7 progressions were obtained. The partial response lasted 7 months and occurred in a patient with locally advanced squamous cell carcinoma, already treated by RT and cisplatin-VP-16-213.

Median survival was 41 weeks. The major toxicity was marrow toxicity: leukopenia (WBC nadir < 2000/mm ) was present in i0 pts (59%) and life-threatening thrombocytopenia occurred in 3 pts. Anemia and alopecia were common. Seve- re vomiting in 3 pts, moderate stomatitis in 2, diarrhoea in I, melano~ermia in 1 and mild peripheral neuropathy in 1 were side effects also observed.

In conclusion VM26 is rather ineffective in NSCLC at the dose and schedule that we applied, though it has been recently demonstrated to be an active drug in small cell histology.

Second Line Treatment With VM 26, Doxorubicin (DXR) and BCNU For Relapsed Non Small Cell Lung Cancer (NSCLC).

Araujo, C., DeMarco, H., Batagelj, E., Saporiti,