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Radiotherapy combined with daily platinum chemotherapy in inoperable non-small-cell lung cancer (NSCLC)
Abshncts
s30
IIIB NSCLC. We previously evaluated feasibility and activity of a CDDP-based regimen consisting of CDDP 80 mg/m* and IF0 3 g/m2 on day 1, NVB 25 mg/m* on days 1,8 (VIP) in 76 NSCLC stage IIIB-IV pts [Baldini et al. 1996 Ann Oncol 2747-7491. After chemotherapy, stage RIB patients (pts) with complete or partial response (CR, PR), or stable disease (SD) were proposed for thoracic RT (200 cGy/6 weeks/60 Gy). Nineteen pts with WHO performance status (PS) < 2, were enrolled for RT after 3-6 cycles of VIP; 13/19 pts started RT (3/19 refused RT, in l/19 PS worsened (> 2) and 2/19 were treated outside with a cobalt unit). Four pts did not complete RT, one stopped for pneumonitis and three for progression of disease (PD). One pt interrupted RT for 24 days after 4 Gy because of grade 4 leukothrombocytopenia. All 13 pts were evaluable for acute and late RT related toxicity. Grade 3 dysphagia or pneumonitis were observed in four pts and grade 4 leuko-thrombocytopenia in one pt. Three pts developed hilar and six pts paramediastinal fibrosis. Comparing tumor volume before and after RT, we observed five PR, three SD and one PD. First site of recurrence was local in seven pts. distant in three pts and both local and distant in one pt. At last follow-up two pts were unprogressed. Median survival and PFS of 13 pts treated with RT were, respectively, 26 months (7-42 + ) and 14 months (4-36). Thoracic RT was quite well tolerated after 3-6 VIP cycles, only 2/13 (15.3%) pts had to interrupt or to stop definitely RT. Thoracic RT reduces residual tumor volume after chemotherapy in five pts out of 13 (38.5%), but local recurrences are still frequent (7 + 1),61.5%. Vinorelbine plus cisplatin and concurrent radiotherapy in non-small cell lung cancer Zatloukal P, Pettielka L, Zemanova M, Krejbich F, Have1 L. Czech Lung
Cancer Cooperative
Group,
Prague,
Czech Republic.
Purpose: To assess the feasibility, toxicity and efficacy of concurrent chemoradiotherapy using cisplatin plus vinorelbine regimen. Patients: From July 1996 to June 1997, 20 patients were enrolled: 15 males, five females; mean age 61.1 years (range 44-73), mean Kamofsky PS 87; histology: squamous 15, large cell 2, adenosquamous 1, adenocarcinoma 1, undifferentiated 1; clinical stage IIIA 4, IIIB 16 pts. Treatment: Chemotherapy (CT) consists of four cycles of cisplatin 80 mg/m’ on day 1 and vinorelbine 25 mg/m2 on days 1, 8, 15. The dose of vinorelbine was reduced to 12.5 mg/m* during cycle 2 and 3. Cycles were repeated every 4 weeks and the beginning was scheduled on Fridays. Radiotherapy CRT) started from day 4 of cycle 2 (60 Gy/30 fr/6 weeks). RT was given prior to CT on days 8, 15 (cycle 21 and 1, 8, 15 (cycle 3) and was followed by two weekend days rest. Results: Sixteen out of 20 pts were evaluable for response. The overall objective response rate was 62.5%, with 18.7% of the evaluated pts experiencing a complete response. The treatment was well tolerated. WHO grade 3 or 4 toxicity: anemia 5%, leucopenia 26%, nausea/vomiting 16%, esophagitis 5% of cycles. Febrile neutropenia occured in 9% of cycles and was not severe. There was no treatment related death. Data on survival and duration of response will be presented at ASCO meeting. Conclusion: Our preliminary results confirm the significant
activity and favorable toxicity profile of concurrent chemoradiotherapy using cisplatin plus vinorelbine regimen. Low incidence of esophagitis is probably due to the schedule in which RT precedes CT and following two weekend days rest avoids radiation injury of tissue highly saturated by cytostatic agents. These promising results have led to activation of a randomized trial comparing concurrent versus sequential chemoradiotherapy. Radiotherapy combined with daily platinum chemotherapy in inoperable non-small-cell lung cancer (NSCLC) Raymond* S, Beckendorf** V, Spaeth** D, Hailer* MA, Scheid* P, Martinet* Y. *Fidimtion de Fneumologie CHQ and **Department of Nancy, France.
of Radiotherapy,
Centre A. Vautrin,
University
Radiotherapy combined with platinum has been proposed, since 1990, in the treatment of inoperable NSCLC, however with conflicting results in respect to survival and life quality. Retrospectively, 40 inoperable NSCLC [stages I-II (n = 3), IIIA (n = 31, IIIB (n = 341, male (n = 351, age (57.9 f 10.4)] underwent continuous course radiotherapy [curative (55 Gy, n = 261, or palliative (< 45 Gy, n = 1411, with concomitant chemotherapy: cisplatin 6 mg/m*/day (n = 221, carboplatin 15 mg/m2/day (n = 121, cisplatin with 5 FU (n = 51, or VP16 (n = 1). Twenty objective responses [complete (n = 91, partial (n = 1111, a median survival of 12 months (curative: 14.2 vs. palliative: 8.8 months, P < 0.051, and a median progression free interval of 10.3 months were observed, with 1, 2 and 3 year survival rates of 47,21.5 and 12%, and the following toxic events: neutropenia (n = 21, thrombopenia (n = 41, esophagitis gr.4 (n = 31, nausea (n = 2). Radiotherapy was discontinued for: toxicity (n = 31, progression (n = 11, refusal (n = 1). In view of a historical study with a 13% survival rate at 2 years [C. Blanke, 1995 .I Clin Oncol 1995 13:1425-291, this study suggests the interest of adding platinum chemotherapy to radiotherapy. A phase I/II trial of neoadjuvant chemotherapy with cisplatin and vinorelbine followed by accelerated concomitant boost irradiation in inoperable non-small cell lung cancer Viallet* J, Brassard* MA, Souhamii L, Ayoub* J, Del Vecchio* P, Rousseau* P, Kreisman H, Guerra J, Langlebent A, Hohneker J, Leyland-Jones B. *University of Montreal, TMcGill University,
Montreal,
Canada
and Glaxo- Wellcome.
Purpose: We conducted this trial in order to evaluate the tolerability and response rate of NSCLC to a regimen of cisplatin and vinorelbine chemotherapy followed by accelerated thoracic radiotherapy. Patients and Methods: From October 1992 to November 1994, we accrued 42 eligible patients with inoperable and measurable stages IRA and IIIB NSCLC with a Karnofsky performance score 2 70. Patients with a history of weight loss were not excluded. Treatment consisted of cisplatin 100 mg/m’ on day 1 of weeks 1 and 5 and vinorelbine 30 mg/m’/week X 5 with a planned 50% dose reduction to 15 mg/m* on week 2. This was followed by thoracic irradiation of 60 Gy in 30 fractions of 2 Gy over 4 weeks (once daily on week 1 and 2 and twice daily on weeks 3
s30
IIIB NSCLC. We previously evaluated feasibility and activity of a CDDP-based regimen consisting of CDDP 80 mg/m* and IF0 3 g/m2 on day 1, NVB 25 mg/m* on days 1,8 (VIP) in 76 NSCLC stage IIIB-IV pts [Baldini et al. 1996 Ann Oncol 2747-7491. After chemotherapy, stage RIB patients (pts) with complete or partial response (CR, PR), or stable disease (SD) were proposed for thoracic RT (200 cGy/6 weeks/60 Gy). Nineteen pts with WHO performance status (PS) < 2, were enrolled for RT after 3-6 cycles of VIP; 13/19 pts started RT (3/19 refused RT, in l/19 PS worsened (> 2) and 2/19 were treated outside with a cobalt unit). Four pts did not complete RT, one stopped for pneumonitis and three for progression of disease (PD). One pt interrupted RT for 24 days after 4 Gy because of grade 4 leukothrombocytopenia. All 13 pts were evaluable for acute and late RT related toxicity. Grade 3 dysphagia or pneumonitis were observed in four pts and grade 4 leuko-thrombocytopenia in one pt. Three pts developed hilar and six pts paramediastinal fibrosis. Comparing tumor volume before and after RT, we observed five PR, three SD and one PD. First site of recurrence was local in seven pts. distant in three pts and both local and distant in one pt. At last follow-up two pts were unprogressed. Median survival and PFS of 13 pts treated with RT were, respectively, 26 months (7-42 + ) and 14 months (4-36). Thoracic RT was quite well tolerated after 3-6 VIP cycles, only 2/13 (15.3%) pts had to interrupt or to stop definitely RT. Thoracic RT reduces residual tumor volume after chemotherapy in five pts out of 13 (38.5%), but local recurrences are still frequent (7 + 1),61.5%. Vinorelbine plus cisplatin and concurrent radiotherapy in non-small cell lung cancer Zatloukal P, Pettielka L, Zemanova M, Krejbich F, Have1 L. Czech Lung
Cancer Cooperative
Group,
Prague,
Czech Republic.
Purpose: To assess the feasibility, toxicity and efficacy of concurrent chemoradiotherapy using cisplatin plus vinorelbine regimen. Patients: From July 1996 to June 1997, 20 patients were enrolled: 15 males, five females; mean age 61.1 years (range 44-73), mean Kamofsky PS 87; histology: squamous 15, large cell 2, adenosquamous 1, adenocarcinoma 1, undifferentiated 1; clinical stage IIIA 4, IIIB 16 pts. Treatment: Chemotherapy (CT) consists of four cycles of cisplatin 80 mg/m’ on day 1 and vinorelbine 25 mg/m2 on days 1, 8, 15. The dose of vinorelbine was reduced to 12.5 mg/m* during cycle 2 and 3. Cycles were repeated every 4 weeks and the beginning was scheduled on Fridays. Radiotherapy CRT) started from day 4 of cycle 2 (60 Gy/30 fr/6 weeks). RT was given prior to CT on days 8, 15 (cycle 21 and 1, 8, 15 (cycle 3) and was followed by two weekend days rest. Results: Sixteen out of 20 pts were evaluable for response. The overall objective response rate was 62.5%, with 18.7% of the evaluated pts experiencing a complete response. The treatment was well tolerated. WHO grade 3 or 4 toxicity: anemia 5%, leucopenia 26%, nausea/vomiting 16%, esophagitis 5% of cycles. Febrile neutropenia occured in 9% of cycles and was not severe. There was no treatment related death. Data on survival and duration of response will be presented at ASCO meeting. Conclusion: Our preliminary results confirm the significant
activity and favorable toxicity profile of concurrent chemoradiotherapy using cisplatin plus vinorelbine regimen. Low incidence of esophagitis is probably due to the schedule in which RT precedes CT and following two weekend days rest avoids radiation injury of tissue highly saturated by cytostatic agents. These promising results have led to activation of a randomized trial comparing concurrent versus sequential chemoradiotherapy. Radiotherapy combined with daily platinum chemotherapy in inoperable non-small-cell lung cancer (NSCLC) Raymond* S, Beckendorf** V, Spaeth** D, Hailer* MA, Scheid* P, Martinet* Y. *Fidimtion de Fneumologie CHQ and **Department of Nancy, France.
of Radiotherapy,
Centre A. Vautrin,
University
Radiotherapy combined with platinum has been proposed, since 1990, in the treatment of inoperable NSCLC, however with conflicting results in respect to survival and life quality. Retrospectively, 40 inoperable NSCLC [stages I-II (n = 3), IIIA (n = 31, IIIB (n = 341, male (n = 351, age (57.9 f 10.4)] underwent continuous course radiotherapy [curative (55 Gy, n = 261, or palliative (< 45 Gy, n = 1411, with concomitant chemotherapy: cisplatin 6 mg/m*/day (n = 221, carboplatin 15 mg/m2/day (n = 121, cisplatin with 5 FU (n = 51, or VP16 (n = 1). Twenty objective responses [complete (n = 91, partial (n = 1111, a median survival of 12 months (curative: 14.2 vs. palliative: 8.8 months, P < 0.051, and a median progression free interval of 10.3 months were observed, with 1, 2 and 3 year survival rates of 47,21.5 and 12%, and the following toxic events: neutropenia (n = 21, thrombopenia (n = 41, esophagitis gr.4 (n = 31, nausea (n = 2). Radiotherapy was discontinued for: toxicity (n = 31, progression (n = 11, refusal (n = 1). In view of a historical study with a 13% survival rate at 2 years [C. Blanke, 1995 .I Clin Oncol 1995 13:1425-291, this study suggests the interest of adding platinum chemotherapy to radiotherapy. A phase I/II trial of neoadjuvant chemotherapy with cisplatin and vinorelbine followed by accelerated concomitant boost irradiation in inoperable non-small cell lung cancer Viallet* J, Brassard* MA, Souhamii L, Ayoub* J, Del Vecchio* P, Rousseau* P, Kreisman H, Guerra J, Langlebent A, Hohneker J, Leyland-Jones B. *University of Montreal, TMcGill University,
Montreal,
Canada
and Glaxo- Wellcome.
Purpose: We conducted this trial in order to evaluate the tolerability and response rate of NSCLC to a regimen of cisplatin and vinorelbine chemotherapy followed by accelerated thoracic radiotherapy. Patients and Methods: From October 1992 to November 1994, we accrued 42 eligible patients with inoperable and measurable stages IRA and IIIB NSCLC with a Karnofsky performance score 2 70. Patients with a history of weight loss were not excluded. Treatment consisted of cisplatin 100 mg/m’ on day 1 of weeks 1 and 5 and vinorelbine 30 mg/m’/week X 5 with a planned 50% dose reduction to 15 mg/m* on week 2. This was followed by thoracic irradiation of 60 Gy in 30 fractions of 2 Gy over 4 weeks (once daily on week 1 and 2 and twice daily on weeks 3