Abstracts/Lung Cancer 12 (1995) 265-329

with that observed at II LOO-mg/m’ dose. The number of infusional reactions and rash decreased when ducetaxcl at this dose was administered with prednisune. Based on response rates observed in trials using a lOO-mg/m’ dose with similar degrees of neutropcnia, a IOO-mg/m* dose with steroid pretreatment is recommended future trials.

L&au B, Chastang C, Schuller MP, Thiberville L, Vaylet F, Derenne JP et al. Service de Pneumoiogie, Hopital Soin&Antoine, 184, Rue du Fg Saint-Antoine, F 75571 Paris Cedex 12. Presse Med 1995;24:217-21.

Objdive: Prethempeutic prognostic factors for patients given chemotherapy for small cell lung carcinoma have been widely studied. We evaluated response to chemotherapy in patients included in 4 multicentric trials with less restrictive entry criteria in order to determine the contribution of clinical outcome as a predictive factor. Mefhods: Pretherapcutic and therapeutic prognostic factors were assessed in I280 patients included in 4 suootssive multicentric lherapeutic trials on chemotherapy for small cell lung carcinoma conducted from January 1, 1983 to April I, 1992. Log rank test for univariate analysis and Cox’s stepwise method for multivariate analysis were used to evaluate the results. Remd~~: Univariate analysis identified prcthempeutic factors as significant for prognosis: Kamofsky index (p < O.OOOl), alkaline phusphattxe level (p 4 0.0002). white cell count (p < O.COOS), age (p = 0.0007), presence of brain metastasis (p = 0.0004), presenoc of Iiver metastasis (p = 0.03). initial extension (p = 0.04). Multivariate analysis taking into account prethcmpcutic and therapeutic factors demonstrated that complete response after the second and after the sixth treatment session were predictive of longer survival (p < O.CNOl). This factor was mom powerfiil than all the prctherapeutic factors including the Kamofsky index, initial extension and brain metastasis. Conclusion: For patients with .~mall cell lung carcinoma, the prognostic value of early response to chemotherapy suggests that high doses should be used starting at the first session.

SrmlleellLunguafer(SCLC):Arnndomiaedtrillofcydophojpbamide, adriamycio, vincristine phus etopaside (CAV-E) or teniposide (CAV-T) as iadoctioa treatment, fohwed in complete responders by alfa-inter- feron or no treatment, as maintenance tberapy Tummarello D, Gntziano F. Mari D, Cetto G, Pesini F, Antonio S. Cattedra di OncologioMedica. Ospedale Regionale Tom~te. 601 OOAncona. Anticancer Res 1994;14:2221-7.

In this phase III, double-random study, we compared CAV-E to CAV-T combination as induction treatment (1st randomization) for SCLC. Subsequently, patients achieving a complete response (CR) were randomized again (2nd randomization) to receive maintenance treatment with &IFN or no treatment. From June 1990 to June 1992.75 untreated patients were enrolled in this trial. At?cr stratiticetion according to limited disease (LD) or extensive disease (ED), patients were randomized to receive the following treatment: cyclophosphamide 1000 mglm2, adriamycin 50 mgim2, vincristine 2 mg, day 1 i.v., plus etoposide (E) 100 m#m2 (CAV-E arm-A) or teniposide (T) 60 m&2 on day 2,3,4 i.v., every 3 weeks (CAV-T: arm-B). LD patients after 3 cycles of treatment received chest radiotherapy and 2 further cycles, whereas ED patients received 5 consecutive cycles. Patients who achicvcd a CR entered the 2nd randomization receiving &FN (3~10~ LU., i.m. daily x 9 months) or no treatment. A second- line treatment with carboplatin 300 mg/m2 plus E (if T was initially used) or T (if E was initially used) was also scheduled for patients achieving less than CR to induction treatment. Preliminary results are as follows: 75 patients were nmndomized, 72 were ciigible for survival (arm-A = 37 and arm-B = 35) and 60 were fully cvaluablc for response (arm-A = 34 and arm-B = 26). In patients with LD the overall response rate was 79% (CR 21%) in arm-A vs 92% (CR 50%) in arm-B. In patients with ED, the overall response rate was 80% (CR 33%) in am- A vs 84% (CR 7%) in arm-B. At a mean observation time of about 1 year (range l-25 months), median survival of LD patients was 15 months in arm-A and 13 months in arm-B (Chi-square = 1.55; pXl.05); in ED patients survival was 10.8 months and 8 months respectively (Chi-square = 2.88; ~0.05). Cumulative survival probability was identical (12 months) in all patients of both arms. Toxicity was mainly haematologic and gastrointestinal: WHO grade 3-4 myelosuppression and vomiting were observed in 20% and 11% respectively, of cycles delivered in snn-A. compared to 19% and 8% respectively, of cycles in

arm-B. Two septic deaths occurred with CAV-T, while I patient discontinued treatment due to persistent myelosuppression with CAV-E. After the first and second-line treatment 20 patients showed a CR. Five of them refused further treatment, while I5 accepted to enter the 2nd randomization. At the time of analysis, 9 patients were allocated to the &FN arm and 6 to the control arnx Although the study is still running, the 2nd randomization accrual appears inadequate to achieve the second objective within a rasunablc time.

Radicll radiotherapy for early nonsmall cell lung cancer Graham PH, Gebski VJ, Lagslands AO. Deporbnenr of Radiafion Oncology Westmead Hospifal, Westmead. NSW 214.5. Int J Radiat One01 Biol Phys 1995;31:261-6.

Purpose: To evaluate the results of a departmental treatment policy in a consecutive series of patients with nonsmall cell carcinoma of the lung. A second purpose was to estimate the survival of patients treated with radical intent. A third purpose was to estimate the impact of comorbidity on the selection of patients for treatment and on its outcome. Melhods and Makriak The records of 720 consecutive patients referred to a single Department ofRadiation Oncology between 1979 and 1985 were reviewed. One hundred tit@ patients with early stage (Stage I and II disease) were studied in detail and the results are presented for the outcome of 103 patients treated by radical radiotherapy. All patients were followed for a minimum period of five years or until death. Remk Patients referred for radiation therapy were elderly and usually had squamous cell carcinoma of the lung. &morbidity was significant as was weight loss which uccurred in a third of patients. The overall survival of patients treated with radical intent was 13%. In a small subgroup of patients with T, tumors without weight loss and aged under 70 survival teached 50% at 5 years with no treatment-related mortality and with insignificant treatment-related morbidity. Conclusion: Highly selected subsets of patients suitable for treatment with radiotherapy can be defined equally as well as highly s&&d subsets of patients can be selected for surgery. Treatment outcome can be surprisingly guud in these subsets indicating that the treatment of nonsmall cell lung cancer, particularly in older patients without comorbidity should nut automatically be by a surgical approach.

Is carboplatin and oral etoposide an etktive and feasible regimen in patients with small cell hmgcancer? Pfeiffer P, Sorensen P, Rose C. Lkparbnenl o/Oncology R, Odense Universi& Hospilal, DK-5000 Odense C. Eur J Cancer Past A Gen Top 1995;31:64-9.

The combination of carboplatin and ctoposide is an active and well-tolerated regimen in the treatment of small cell lung cancer (SCLC). The aim of the study was to confirm whether the efficacy could be maintained if etoposide was administered orally. 166 consecutive, unselected, and untreated patients with SCLC (limited disease (LD) 44; extensive disease (ED) 62) were treated with a combination of carboplatin 300 mp/m’ intravenously (i.v.) day 1 and ctoposide 240 mgfd orally days 1-3 every 4 weeks for six courses or until progression. If oral treatment was inconvenient, i.v. etoposidc (120 mp/m’ days l-3) was allowed. Thoracic irradiation (45 Gy in 22 fractions, split course) was given st?er three courses of chemotherapy to 29 patients with LD. Objective response (complete and partial) was seen in 89% (confidence interval (CI) 75-97) of patients with LD and in 53% (CI 40-66) with ED. Complete response was seen in 41% (CE 26-57) of patients with LD and in 8% (CI 2-18) with ED. Median time to progression for responders was I I months and 6 months for patients with LD and ED, respectively. Corresponding median survival was 15 months (range 145 months) and 8.5 months (O-26 months). Myelosupprcssion comprised the main toxicity. Leucopenia (WHO I&IV) was observed in 20% and thrombocytopenia (WHO III-IV) in 16% of the cases. One patient died of sepsis during leucopenia. Oral treatment was convenient for most patients and therapy well tolerated. However, 9 patients (20%; CI 9-36%) with LD and 26 patients (42%; CI 29- 56%) with ED received at least part of the etopuside treatment i.v.. The present study shows that the combination of carboplatin and oral etoposlde is active and well tolerated, and may be used on an outpatient basis in pabents with small cell lung ca”cer.