High-dose cisplatin with dipyridamole in advanced non-small cell lung cancer: A Grupo Oncologico...

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Abstracts/Lung Cancer 13 (1995) 185-232 221 containing cartoplatin do not differ from literary results obtained by The possible role of autotransplantation in small cell lung cancer standard therapy (cisplatin and etoposide). Due to good tolerance and Tiefengraber E, Sebesta C, Kier P, Ruckser R, Habertheuer KH, oneday administration the above schemes are suitable for out-patient Hinterberger W. Ludwig-BoItzmann-Inst. Stommzeli., DSZO, Longo- treatment which, from the point of view of the quality of life is more banienshose 122. A-1220 men. Wien Med Wochenschr 1995;145:50- suitable for the patients than the treatment under hospitalization. 2. High-dose cisplatin with dipyridamole in advanced non-small cell lung cancer: A Grupo Oncologico Cooperativo del Sur study Vallejo CT, Rabinovich MG, Perez JE, Rodriguez R, Machiavelli MR Leone BA et al. GOCS, H. Irigoyen 446 (SSOO), Neuquen. Am J Clin Oncol Cancer Clin Trials 1995;18: 185-8. Autoloaous bone marrow transolantation (ABMT) oerformed with recent achi‘kvements plays yet no kstablished‘role in’the treatment of small cell lung cancer (SCLC). The majority of treatment results obtained so far do not clearly suggest a superiority of bighdose therapy with autologous transplantation over conventional polychemo/radiotherapy. It is unknown, whether or not a subgroup ofpatients with, e.g., ‘limited disease’ and chemosensitive tumor may benefit from ABMT. Ran- domized trials will be necessary to clarify this question. From March 1991 to October 1992,41 patients with advanced non- small cell lung cancer (NSCLC) (20 stage IIlB and 2 I stage IV) received a regimen consisting of cisplatin (CP) 100 mg/m* iv. days 1 and 8, and dipyridamole (DPD) IO0 mg p.o. 75 minutes before CR and then at hours 6, 12, and I8 as first-line chemotherapy, Cycles were repeated every 28 days for a total of 3. Median age was 56 years (range: 4070). All patients had a performance status 0 to I and a weight-loss % 10%. Squamous-ceU carcinoma was diagnosed in 19 patients: adenocaminoma in 16, and large-cell carcinoma in 6. A total of 37 patients were fully waluable for response, whereas 39 were assessable for toxicity. No complete responses were observed: 5 patients (14%) achieved partial response: 23 patients (62%) showed no change, and progressive disease was observed in 9 (24%). The median time to treatment failure was 4 months, whereas median survival was 8 months. The average dose intensity received at the end of the third course of therapy was 46 mg/ m2/week. There were no drug-related deaths. Toxicity was mild to moderate, with a high incidence of ototoxicity (54%) and emesis (67%). In conclusion, these results failed to demonstrate any significant advantage from a high-dose CP regimen modulated by DPD in patients with advanced NSCLC. The effect of mitomycin-c, vinblastine, and cisplrtin(MVP) combined chemotherapy in non-small cell lung cancer Kim Y-W, Park N-H, Ji S-K, Choi H-M, L.ee S-H, Lee K-H. Department of Internal Medicine, College of Medicine Kosin University, Pusan. Tuberc Respir Dis 1995;42:76-83. Dose intensification - A phase I study of ifosfamide with vinorelbine (Navelbine): Rationale and study design in advanced non-small cell lung cancer Drinkard LC, Hoffman PC, Samuels BL, Watson S, Bitran JD, Golomb HM et al. Section of Hematology/Oncology. Department ofMedicine, University of Chicago Medical Cente,: 5841 SMatylandAve, Chicago, IL 60613. Semin Oncol 1995:22:Suppl 5:30-7. A phase I trial ofa combination of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France) and ifosfamide given on a novel schedule on 3 consecutive days with granulocyte colony-stimulating factor was conducted to establish the maximum tolerated dose of vinorelbine and the dosc- limiting toxicities of this regimen. Doses of vinorelbine were escalated in cohorts of patients. Gf the 29 patients enrolled at the time of data analysis, 26 were evahtable for toxicity. At the first dose level (ifosfamide 2.0 g/m’ days 1,2, and 3; vinorelbine 15 mg/mz days I, 2, and 3). two of three patients had dose- limiting toxicities. The dose of ifosfamide was decreased by 20%, and dose escalation ofvinorelbine was restarted. At the vinorelbine dose level of 35 mglm2/d for 3 days, three of four patients had dose-limiting toxicities. The recommended phase II doses were established as 1.6 g/m’/d ifosfamide for 3 days and 30 mg/mtld vinorelbine for 3 days. This study established that granulocyte colony- stimulating factor was needed for approximately 8 days. We are currently examining the feasibility of two dose levels of vinorelbine (25 mplm’ and 30 mg/m*/d for 3 days) in combination with ifosfamide (1.6 g/m’/ d) given every 2 weeks. Bockgtmmd: Despite advances in chemotherapy, the treatment of inoperable non-small cell carcinoma ofthe lung remains poor. According to the recent reports, the response rates of mitomycin, vinblastine, and cisplatin(MVP) chemotherapy are higher than those of other cisplatin based polychemotherapy and MVP chemotherapy can be used as neoadjuvant chemotherapeutic regimen. But the overall response rates of MVP chemotherapy range from 17 to 53 percent, so we studied the effect of MVP chemotherapy in advanced non-small cell lung cancer. Method: We treated forty patients with stage III or IV non-small cell lung cancer with two courses of MVP chemotherapy(8mg/m2 of mitomycin on day 1, bmg/m’ of vinblastine on day 2 and day 14, and lOOmg/m* of cisplastin on day 1) at 4 weeks interval. Then all patients were evaluated the response ofchemotherapy 4 weeks later, and received further chemotherapy, palliative radiotherapy or supportive therapy according to the patient’s condition. We also determined the median survival time and prognostic factors. Results: 1) Nine patients(23%) had a partial reponse, 23 patients(57%) had a stable disease, and disease progressed in 8 patients(20%). There were no patients with complete response. 2) The overall median survival time was 36 weeks(range, 9 to 119+ weeks). The median survival time of responder(panial response) and non-responder(stable and progressed) groups were 60 weeks(range, 36 to 82+ weeks) and 3 I weeks(range, 9 to 119+ weeks) respectively (p=O.O3). 3) The median survival time of the female group was 71 weeks and signiticantly prolonged in comparison with 35 weeks of the male group@=o.O 1). But, the other prognostic factors didn’t alfect the survival time and response rate. 4) The median survival times of chemotherapy group and chemotherapy with palliative radiotherapy group were not signiticantly different. Conclusion: MVP combined chemotherapy is unsatisfactory in improving survival in advanced non-small cell lung cancer. Therefore, further studies are needed to find more active new agents and to establish the efficacy of the combined treatment with radiotherapy and/or surgery. Phase 11 study of daily oral etoposide plus ifosfamide plus cisplatin for previously treated recurrent small-cell lung cancer: A Hoosier Oncology Group trial Faylona EA. Loehrer PJ, Ansari R Sandler AB, Gonin R Einhom LH. Hoosier Oncology Group, 3202 NMeridian, Indianapolis, IN 46208. J Clin Oncol 1995; 13:1209-14. Purpose: The study was undertaken to determine the activity and toxicity of oral etoposide (VP-16), ifosfamide, and cisplatin combination

Transcript of High-dose cisplatin with dipyridamole in advanced non-small cell lung cancer: A Grupo Oncologico...

Page 1: High-dose cisplatin with dipyridamole in advanced non-small cell lung cancer: A Grupo Oncologico Cooperativo del Sur study

Abstracts/Lung Cancer 13 (1995) 185-232 221

containing cartoplatin do not differ from literary results obtained by The possible role of autotransplantation in small cell lung cancer standard therapy (cisplatin and etoposide). Due to good tolerance and Tiefengraber E, Sebesta C, Kier P, Ruckser R, Habertheuer KH, oneday administration the above schemes are suitable for out-patient Hinterberger W. Ludwig-BoItzmann-Inst. Stommzeli., DSZO, Longo- treatment which, from the point of view of the quality of life is more banienshose 122. A-1220 men. Wien Med Wochenschr 1995;145:50- suitable for the patients than the treatment under hospitalization. 2.

High-dose cisplatin with dipyridamole in advanced non-small cell lung cancer: A Grupo Oncologico Cooperativo del Sur study Vallejo CT, Rabinovich MG, Perez JE, Rodriguez R, Machiavelli MR Leone BA et al. GOCS, H. Irigoyen 446 (SSOO), Neuquen. Am J Clin Oncol Cancer Clin Trials 1995;18: 185-8.

Autoloaous bone marrow transolantation (ABMT) oerformed with recent achi‘kvements plays yet no kstablished‘role in’the treatment of small cell lung cancer (SCLC). The majority of treatment results obtained so far do not clearly suggest a superiority of bighdose therapy with autologous transplantation over conventional polychemo/radiotherapy. It is unknown, whether or not a subgroup ofpatients with, e.g., ‘limited disease’ and chemosensitive tumor may benefit from ABMT. Ran- domized trials will be necessary to clarify this question.

From March 1991 to October 1992,41 patients with advanced non- small cell lung cancer (NSCLC) (20 stage IIlB and 2 I stage IV) received a regimen consisting of cisplatin (CP) 100 mg/m* iv. days 1 and 8, and dipyridamole (DPD) IO0 mg p.o. 75 minutes before CR and then at hours 6, 12, and I8 as first-line chemotherapy, Cycles were repeated every 28 days for a total of 3. Median age was 56 years (range: 4070). All patients had a performance status 0 to I and a weight-loss % 10%. Squamous-ceU carcinoma was diagnosed in 19 patients: adenocaminoma in 16, and large-cell carcinoma in 6. A total of 37 patients were fully waluable for response, whereas 39 were assessable for toxicity. No complete responses were observed: 5 patients (14%) achieved partial response: 23 patients (62%) showed no change, and progressive disease was observed in 9 (24%). The median time to treatment failure was 4 months, whereas median survival was 8 months. The average dose intensity received at the end of the third course of therapy was 46 mg/ m2/week. There were no drug-related deaths. Toxicity was mild to moderate, with a high incidence of ototoxicity (54%) and emesis (67%). In conclusion, these results failed to demonstrate any significant advantage from a high-dose CP regimen modulated by DPD in patients with advanced NSCLC.

The effect of mitomycin-c, vinblastine, and cisplrtin(MVP) combined chemotherapy in non-small cell lung cancer Kim Y-W, Park N-H, Ji S-K, Choi H-M, L.ee S-H, Lee K-H. Department of Internal Medicine, College of Medicine Kosin University, Pusan. Tuberc Respir Dis 1995;42:76-83.

Dose intensification - A phase I study of ifosfamide with vinorelbine (Navelbine): Rationale and study design in advanced non-small cell lung cancer Drinkard LC, Hoffman PC, Samuels BL, Watson S, Bitran JD, Golomb HM et al. Section of Hematology/Oncology. Department ofMedicine, University of Chicago Medical Cente,: 5841 SMatylandAve, Chicago, IL 60613. Semin Oncol 1995:22:Suppl 5:30-7.

A phase I trial ofa combination of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France) and ifosfamide given on a novel schedule on 3 consecutive days with granulocyte colony-stimulating factor was conducted to establish the maximum tolerated dose of vinorelbine and the dosc- limiting toxicities of this regimen. Doses of vinorelbine were escalated in cohorts of patients. Gf the 29 patients enrolled at the time of data analysis, 26 were evahtable for toxicity. At the first dose level (ifosfamide 2.0 g/m’ days 1,2, and 3; vinorelbine 15 mg/mz days I, 2, and 3). two of three patients had dose- limiting toxicities. The dose of ifosfamide was decreased by 20%, and dose escalation ofvinorelbine was restarted. At the vinorelbine dose level of 35 mglm2/d for 3 days, three of four patients had dose-limiting toxicities. The recommended phase II doses were established as 1.6 g/m’/d ifosfamide for 3 days and 30 mg/mtld vinorelbine for 3 days. This study established that granulocyte colony- stimulating factor was needed for approximately 8 days. We are currently examining the feasibility of two dose levels of vinorelbine (25 mplm’ and 30 mg/m*/d for 3 days) in combination with ifosfamide (1.6 g/m’/ d) given every 2 weeks.

Bockgtmmd: Despite advances in chemotherapy, the treatment of inoperable non-small cell carcinoma ofthe lung remains poor. According to the recent reports, the response rates of mitomycin, vinblastine, and cisplatin(MVP) chemotherapy are higher than those of other cisplatin based polychemotherapy and MVP chemotherapy can be used as neoadjuvant chemotherapeutic regimen. But the overall response rates of MVP chemotherapy range from 17 to 53 percent, so we studied the effect of MVP chemotherapy in advanced non-small cell lung cancer. Method: We treated forty patients with stage III or IV non-small cell lung cancer with two courses of MVP chemotherapy(8mg/m2 of mitomycin on day 1, bmg/m’ of vinblastine on day 2 and day 14, and lOOmg/m* of cisplastin on day 1) at 4 weeks interval. Then all patients were evaluated the response ofchemotherapy 4 weeks later, and received further chemotherapy, palliative radiotherapy or supportive therapy according to the patient’s condition. We also determined the median survival time and prognostic factors. Results: 1) Nine patients(23%) had a partial reponse, 23 patients(57%) had a stable disease, and disease progressed in 8 patients(20%). There were no patients with complete response. 2) The overall median survival time was 36 weeks(range, 9 to 119+ weeks). The median survival time of responder(panial response) and non-responder(stable and progressed) groups were 60 weeks(range, 36 to 82+ weeks) and 3 I weeks(range, 9 to 119+ weeks) respectively (p=O.O3). 3) The median survival time of the female group was 71 weeks and signiticantly prolonged in comparison with 35 weeks of the male group@=o.O 1). But, the other prognostic factors didn’t alfect the survival time and response rate. 4) The median survival times of chemotherapy group and chemotherapy with palliative radiotherapy group were not signiticantly different. Conclusion: MVP combined chemotherapy is unsatisfactory in improving survival in advanced non-small cell lung cancer. Therefore, further studies are needed to find more active new agents and to establish the efficacy of the combined treatment with radiotherapy and/or surgery.

Phase 11 study of daily oral etoposide plus ifosfamide plus cisplatin for previously treated recurrent small-cell lung cancer: A Hoosier Oncology Group trial Faylona EA. Loehrer PJ, Ansari R Sandler AB, Gonin R Einhom LH. Hoosier Oncology Group, 3202 NMeridian, Indianapolis, IN 46208. J Clin Oncol 1995; 13:1209-14.

Purpose: The study was undertaken to determine the activity and toxicity of oral etoposide (VP-16), ifosfamide, and cisplatin combination