Abstracts/Lung Cancer 13 (1995) 185-232 225

Weekly vinorelbine in elderly patients with non-small-cell lung cancer Colleoni M, Gaion F, Nelli P, Colmellere GM, Manenle P. Servirio di Oncologia Medico, Ospedale Civite, U.S.S.L., 13. Ma dell’Ospedale. 31033 Casteljanco Veneto. Tumorl 1994;80:448-52.

Aims and backgmund: Many lung cancers are diagnosed in patients over 65 years of age, but limited data are available on the tolerance and activity in elderly patients of chemotherapy protocols designed for adults. Methods: We therefore activated a phase II study in patients aged 65 years or older affected by stage IIlB-IV non-small-cell lung cancer in order to assess the tolerance and activity of vinorelbine administered weekly at a dose of 25 mg/m*. Results: Since June 1992.25 patients (20 males, 5 females; performance status ECOG, O-2) have been included in the study and are evaluable for response and side eifezts. *o-hundred and twenty-eight cycles of therapy have been delivered (median/patient, 9 cycles). Four partial remissions (16%; 95% confidence interval 5- 360/o)), 9 disease stabilizations, and 12 progressions have been observed. Median time to disease progression was 3 months, and median survival was 5 months (range, Z-25+). Mild or moderate side effects included leukopenia (6 cases), neutropenia (4 cases), anemia (4 cases), nausea (4 cases), infection (3 cases) and thoracic pain (2 cases). Grade III/IV toxicity consisted mainly of leukopenia and neutropenia observed respectively in 5 and in 7 patients. No significant difference in terms of tolerability has been observed for patients aged 65 to 70 with respect to patients aged 70 years or older. Conclusions: The administration of vinorelbine in elderly patients does not seem to differ significantly in terms of response and tolerability from that recorded for adults. Selected elderly patients with good performance status and adequate organ function can be safely treated with systemic chemotherapy.

Adenoid cystic carcinoma of the tracheobronchial system: The role of postoperative radiotherapy Ogino T, Ono R, Shimizu W, Ikeda H. Department of Radiology, National Cancer Center HospitaI East, 6-5-i Kashiwanoha, Koshiwa- sbi, Chiba 277. Radiat Med Imaging Radiat Oncol 1995;13:27-9.

To clarify the role of postoperative radiotherapy for adenoid cystic carcinoma ofthe tracheabronchial system (ACC), we analyzed patients treated at the National Cancer Center Hospital, Tokyo. Seven patients with ACC were treated with resective surgery and postoperative radiotherapy from 1962-1990. None of the primary lesions was completely surgically resected Postoperative irradiation was delivered by standard fractionation at a dose range of 49.2-72 Gy. Four of Seven patients lived more than S years, up to 2 1 years, without local recurrence In contrast, three other patients who showed recurrence within 2 years died of disease before 5 years. Three of four patients who received postoperative irradiation of 60 Gy or more attained local control. One of three patients who received less than 60 Gy failed locally. A high dose of postoperative radiotherapy for patients with a positive surgical margin of ACC seems to improve local control and result in long-term survival.

Phase I/II study of carboplatin and oral etoposide with granulocyte- colony stimulating factor in advanced nonsmall cell lung cancer Frasci G, Perillo G, Comella G, Comella P, Polverino M, Men&la G et al. Casella postale 105. Nocera Inferiore 84014. Salerno. Cancer 1995;75:1578- 85.

Background. A combination of carboplatin (CBDCA) and oral etoposide is better tolerated than, and as effective as, more aggressive chemotherapy regimens in patients with advanced nonsmall cell lung

cancer (NSCLC). A Phase VII study was conducted to determine whether the addition of the granulocytexolony stimulating factor (G-CSF) allows the administration of higher doses of CBCDA. Mefhods. The starting dose of CBDCA was 300 mglmlon day 1 every 28 days, in combination with a fixed dose of oral etoposide 50 mg/m?/day days I-2 1. G-CSF (5 @/kg/day subcutaneously) was admiuistered from day 7 until postnadir neutrophil count of more than lO,OOO/mm’, and from day 25 through day 28. Results. From March 1991 to November 1993, 39 previously untreated patients with NSCLC (18 Stage IlIb and 2 1 Stage IV) entered this trial. Overall eight patients experienced dose-limiting toxicity in the first two courses. Five ofthem were older than 70 years. Age, CBDCA dose, CBDCA area under the curve (AUC), and performance status were correlated with severe neutropenia and thrombocytopenia, but carboplatin AUC was the only independent variable predictive of severity ofboth at multiple regression analysis. Thrombocylopenia was the major dose-limiting toxicity in this study. The maximum tolerated CBDCA dose and AUC were 600 mg/m’ and 8 respectively. No treatment-related death occurred. There was 1 (2.5%) complete response and 14 (36%) partial responses (overall response rate of 38.5%). AUC was more predictive of response achievement than carhoplatin dose. Higher carboplatin dose and AUC were also associated with longer survival by univariate analysis, but by Cox regression analysis age was the only parameter independently predictive of survival. Conclusion. The administration of G-CSF permits safe escalation of CBDCA dose and AUC up to 600 mg/m* and 8 respectively, in combination with a fixed dose of oral etoposide. Age older than 70 years represents a major obstacle to dose escalation. The increase of the body exposure to carboplatin seems to be associated with a better outcome. The deter- mination of CBDCA AUC permits a better prediction of myelotoxicity and response rate.

Relationship between response rate and median survival in patients with advanced non-small cell lung cancer: Comparison of ONCO-NASE(R) with other anticancer agents Mikulski SM, Chun HG, Mittelman A, Panella T, Puccio CA, Shogen K et al. Arfaell Corporation, 225 Befleviite Avenue, Bloomjield, NJ 07003. Int J Oncol 1995;6:889-97.

The role of systemic cytotoxic therapy for the treatment of advanced non-small cell lung cancer (NSCLC) remains controversial. The response rate (TtR) and the median survival time (MST) are the two most frequently used parameters for the assessment of efficacy of the anticancer therapies. The relationship between the previously reported RP.s and MSTs from published chemotherapy trials in patients with advanced NSCLC was examined using linear regression analysis. The MST of the thirty patients with advanced NSCLC treated with ONCONASE (ONC) as a single agent was 7.7 months which compared favorably with the MSTs of patients treated with a variety of chemotherapeutic regimens either as single agents or combinations, as well as placebo and supportive care only. Moreover, the toxicity profile of ONC compared favorably to the protiles of other chemotherapy regimens. ONC had a favorable impact on the overall MST, including patients with stage IV disease, patients with poor performance status, and patients previously treated with radiotherapy and chemotherapy. The MST of 5 patients who had a stabilization of prtiously progressive disease was 9.3 months. Based on its positive impact on the MST, ONC appears to have a single agent activity in patients with advanced NSCLC, and it should be further investigated, particularly in combination with synergistic drugs, in concurrently controlled and prospectively randomized clinical trials. The duration and the quality of survival should be considered as the most meaningful parameters in assessing clinical efficacy of anticancer agents.