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Cisplatin and vinblastine: A salvage chemotherapy (CT) regimen in small cell lung cancer (SCLC)
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7 pretreatment attributes (performance status, extent, mediastinal disease, CEA and LDH levels, liver and brain involvement) were identified as the most significant in the formation of the index. Index scores were found to be predictive of response rates and survival intervals in the analysis of the 480 patient sample. The validity of the prognostic index was tested on a subsequent cohort of 180 patients with SCLC. Index scores correlated predictively with outcome. The index developed herewith provides a consistent integrated approach to prognostic stratification. A universal applicability is proposed as an essential component in the design of clinical trials, the notion of individual risk scores, and in the further elucidation of the interactions between prognostic factors and therapeutic objectives. Refinement of statistical methodology and further validity analysis utilizing larger cohorts in both prospective and retrospective fashion is necessary prior to general usage. C i s p l a t i n A n d Etoposide Followed by Adriamycin and Cytoxan for Treatment of SCLC Limited Disease. Salvati, F., Mugnaini, L., Cruciani, A.R., Portalone, L., Nunziati, F., Antilli, A., Mecarocci, D., Signora, M. 8th Department of Pneumology "Forlanini" Hospital, 00149 Rome, Italy. To evaluate the effectiveness on SCLC of induction combined chemotherapy with cisplatin and VP-16 followed by treatment with adriamycin and cyclophosphamide, 22 pts with limited disease were treated initially with cispl~tin 60 mg/m i.v. day 1 and VP-16 120 mg/m i.v. day 2, 3, 4 every 28 days for 3 courses. After 4 weeks the pts were submitted to combined chemotherapy with adriamycin 59 mg/m i.v. plus cyclophosphamide 600 mg/m- i.v. day 1 every 28 days until progression. Eighteen of 22 entered pts resulted evaluable and the limited stage of their disease was previously determined after careful staging (clinical evaluation, chest tomography, brain CT, abdomen CT, bone scanning, etc.). The median age of treated evaluable pts was 62 years (range 48.72). At present, the results of this trial are the following: Complete response was obtained in 7 pts (CR=38,9%), partial response was obtained in 9 pts (PR=50%) and stable disease in 2 pts (SD=II,I%). In no pt is still appeared progression of disease. The median duration of response resulted in 18 weeks (range 8+ - 38+) and the MST is presently 13 months (range 7-26+). The tolerance was acceptable, particularly renal and G.I. ones. The results so far observed seem to be encouraging (CR+PR rate = 88,9%),
taking into account the low dose of cisplatin and considering that in 3/18 pts the survival exceeds 18 months. Cisplatin and Vinblastine: A Salvage Chemotherapy (CT) Regimen in Small Cell Lung Cancer
(SCLC). Pallotta, G., De Marinis, F., Maccone, C. Pneumological Institute, "C. Forlanini", 3rd Division , 00149 Rome, Italy. Between August 81 and March 83, fifteen patients (pts) with SCLC, resistant to initial CT or relapsed after initial response, were treatedAwith a CT regimen with vinblastine 2 z (8 mg/m i . v . d , i) and cisplatin (i00 mg/m i . v . d . 2) every 21 days until progression. All pts initially were treated with at least 3 cycles of c o ~ i n a t i o n CT with cyclophospham~de (i000 mg/m i . v . d , i), a~riamycin (50 mg/ m- i . v . d , i), VP-16 (i00 mg/m- i . v . d . 1,2,3) every 21 days. The pts limited in CR, followed by RT to the primary and a prophylactic brain irradiation, after which CT was given monthly until progression or at maximum for one year of therapy. The median age of pts was 58, the median PS was 70, 8 pts were LD and 7 ED, the response to initial CT was 5 CR, 1 PR, 9 NR. The median duration of initial response was 9 months(mo) : five pts had progression in metastatic sites (liver, two pts, bone two pts, brain two pts, adrenal glands one pt). None pts resistant to initial CT and four pts relapsed, had objective response to this salvage regimen. Toxicity was moderate. The median survival from the progression was 5 mo (i-i0+), for the entire group from the initial treatment was 9 mo (3-22+). Further studies are needed for a valuation final. Cisplatin, Adriamycin, Etoposide (PAE) vs Cytoxan, Adriamycin, Etoposide (CAE) in The Chemotherapy (CT) of Small Cell Lung Cancer
(SCLC). Pallotta, G., De Marinis, F., Maccone, C. Pneumological Institute "Forlanini", 3rd Division, 00149 Rome, Italy. A total of 49 patients (pts) with untreat 5 ed SCLC were given either cisplating(60 mg/mi . v . d , i), adriamycin (A).(40 mg/m- i . v . d . i), etoposide (E) 580 mg/m z i . v . d . 1,2,3)2or cytoxan (i000 mg/m- i.~. d. i), A (50 mg/m i . v . d , i), E (80 mg/m- i . v . d . 1,2,3), for 6 cycles repeated every 3 weeks. In the PAE group, pts achieving a response received a maintenance non cross resistant CT alternating regimen with CTX, MTC, ADM, VCR, VP-16. In the CAE group, pts in CR received a chest RT and a PCI. There were 23 pts evaluable in PAE group (2 non toxic deaths) and 21 pts in CAE group (3 too early to evaluate). No significant differences were between the groups with respect to prognostic factors. Overall after induction, in limited disease, PAE group gave a 30% of CR and a 80% of CR+PR, a median du-
7 pretreatment attributes (performance status, extent, mediastinal disease, CEA and LDH levels, liver and brain involvement) were identified as the most significant in the formation of the index. Index scores were found to be predictive of response rates and survival intervals in the analysis of the 480 patient sample. The validity of the prognostic index was tested on a subsequent cohort of 180 patients with SCLC. Index scores correlated predictively with outcome. The index developed herewith provides a consistent integrated approach to prognostic stratification. A universal applicability is proposed as an essential component in the design of clinical trials, the notion of individual risk scores, and in the further elucidation of the interactions between prognostic factors and therapeutic objectives. Refinement of statistical methodology and further validity analysis utilizing larger cohorts in both prospective and retrospective fashion is necessary prior to general usage. C i s p l a t i n A n d Etoposide Followed by Adriamycin and Cytoxan for Treatment of SCLC Limited Disease. Salvati, F., Mugnaini, L., Cruciani, A.R., Portalone, L., Nunziati, F., Antilli, A., Mecarocci, D., Signora, M. 8th Department of Pneumology "Forlanini" Hospital, 00149 Rome, Italy. To evaluate the effectiveness on SCLC of induction combined chemotherapy with cisplatin and VP-16 followed by treatment with adriamycin and cyclophosphamide, 22 pts with limited disease were treated initially with cispl~tin 60 mg/m i.v. day 1 and VP-16 120 mg/m i.v. day 2, 3, 4 every 28 days for 3 courses. After 4 weeks the pts were submitted to combined chemotherapy with adriamycin 59 mg/m i.v. plus cyclophosphamide 600 mg/m- i.v. day 1 every 28 days until progression. Eighteen of 22 entered pts resulted evaluable and the limited stage of their disease was previously determined after careful staging (clinical evaluation, chest tomography, brain CT, abdomen CT, bone scanning, etc.). The median age of treated evaluable pts was 62 years (range 48.72). At present, the results of this trial are the following: Complete response was obtained in 7 pts (CR=38,9%), partial response was obtained in 9 pts (PR=50%) and stable disease in 2 pts (SD=II,I%). In no pt is still appeared progression of disease. The median duration of response resulted in 18 weeks (range 8+ - 38+) and the MST is presently 13 months (range 7-26+). The tolerance was acceptable, particularly renal and G.I. ones. The results so far observed seem to be encouraging (CR+PR rate = 88,9%),
taking into account the low dose of cisplatin and considering that in 3/18 pts the survival exceeds 18 months. Cisplatin and Vinblastine: A Salvage Chemotherapy (CT) Regimen in Small Cell Lung Cancer
(SCLC). Pallotta, G., De Marinis, F., Maccone, C. Pneumological Institute, "C. Forlanini", 3rd Division , 00149 Rome, Italy. Between August 81 and March 83, fifteen patients (pts) with SCLC, resistant to initial CT or relapsed after initial response, were treatedAwith a CT regimen with vinblastine 2 z (8 mg/m i . v . d , i) and cisplatin (i00 mg/m i . v . d . 2) every 21 days until progression. All pts initially were treated with at least 3 cycles of c o ~ i n a t i o n CT with cyclophospham~de (i000 mg/m i . v . d , i), a~riamycin (50 mg/ m- i . v . d , i), VP-16 (i00 mg/m- i . v . d . 1,2,3) every 21 days. The pts limited in CR, followed by RT to the primary and a prophylactic brain irradiation, after which CT was given monthly until progression or at maximum for one year of therapy. The median age of pts was 58, the median PS was 70, 8 pts were LD and 7 ED, the response to initial CT was 5 CR, 1 PR, 9 NR. The median duration of initial response was 9 months(mo) : five pts had progression in metastatic sites (liver, two pts, bone two pts, brain two pts, adrenal glands one pt). None pts resistant to initial CT and four pts relapsed, had objective response to this salvage regimen. Toxicity was moderate. The median survival from the progression was 5 mo (i-i0+), for the entire group from the initial treatment was 9 mo (3-22+). Further studies are needed for a valuation final. Cisplatin, Adriamycin, Etoposide (PAE) vs Cytoxan, Adriamycin, Etoposide (CAE) in The Chemotherapy (CT) of Small Cell Lung Cancer
(SCLC). Pallotta, G., De Marinis, F., Maccone, C. Pneumological Institute "Forlanini", 3rd Division, 00149 Rome, Italy. A total of 49 patients (pts) with untreat 5 ed SCLC were given either cisplating(60 mg/mi . v . d , i), adriamycin (A).(40 mg/m- i . v . d . i), etoposide (E) 580 mg/m z i . v . d . 1,2,3)2or cytoxan (i000 mg/m- i.~. d. i), A (50 mg/m i . v . d , i), E (80 mg/m- i . v . d . 1,2,3), for 6 cycles repeated every 3 weeks. In the PAE group, pts achieving a response received a maintenance non cross resistant CT alternating regimen with CTX, MTC, ADM, VCR, VP-16. In the CAE group, pts in CR received a chest RT and a PCI. There were 23 pts evaluable in PAE group (2 non toxic deaths) and 21 pts in CAE group (3 too early to evaluate). No significant differences were between the groups with respect to prognostic factors. Overall after induction, in limited disease, PAE group gave a 30% of CR and a 80% of CR+PR, a median du-