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260 Paclitaxel (Taxol®) and carboplatin followed by concomitant Taxol®, cisplatin and radiotherapy in stage IIIB NSCLC
68
I257
Result of extended resection of the left atrium, great vessels, or both for locally advanced lung cancer
Q.H. Zhou, L.X. Liu, Y. Wang, H.B. Zhang, J.J. Yang, Z.H. Yang. Department of Thoacocarrfiac Surgery; The first University Hospital West China University of Medical Sciences, Chengdu Sichuan 610041, PR China Lung cancer causes the first highest number of cancer-related death in China. But, only one third of patients with lung cancer can be identified as operative candidates. For the other two thirds is inoperable, because they have advanced lung cancer with distant metastasis or locally advanced lung cancer involving neighboring organs. Recently, introduction of the technique of cardiovascular surgery into lung cancer surgery has made possible en bloc resection of the lung combined with part of the involved left atrium, aorta, superior vena cava, and pulmonary artery. One hundred and ten patients with locally advanced lung cancer were admitted into our hospital from February, 1983 to May 1998. A single additional organ was resected in 93 patients, two organs in 14 patients and three organs in 3 cases. Of these patients, combined resection of the lung and left atrium was performed in 42 patients, the pulmonary artery in 82 cases, superior vena cava in 4, and aorta in 2. There was no operative death in this series. The 1 -year, 3-year, and 5year survival rate for all patients was 78.38%, 58.40%, and 35.81% respectively. The 5-year survival rate after left atrium resection was 33.33%. pulmonary artery resection and reconstruction was 38.1%, superior vena cava 25.0% and aorta 50.0% respectively. These results, therefore, suggest that extended resection of the left great vessels, or both was worthwhile for the patients with locally advanced lung cancer.
258 El
Concurrent hyperfractionated thoracic radiotherapy (TRT) with carboplatin and etoposide for the treatment of limited small cell lung cancer (LSCLC)
S. Koinumaru, J. Saito, Y. Nakai. Group, Sendai, Japan
Tohoku
Lung Cancer
Chemotherapy
We conducted a trial to evaluate the efficacy and toxicity of concurrent TRT with carboplatin (C)and etoposide (E) for LSCLC. TRT began from day 2 of first cycle of chemotherapy (CT); 1.5 Gy bid, 5 tiwk x 3 wk. CT consisted of C 300 mg/m* day 1 and E 80 m9/m’ day 1 to 5 q2ld x 4. Since 7’93, 21 patients (p) registered. As of 12’98, 17 p were fully evaluated. All were male, median (M) age; 88 (range; 46-79) PS; O/l/2 = SD/l, stage III A/III B = 918, mean TRT dose; 43.6 Gy (38.4-45.0), CT cycles: l/2/3/4/4+ = 2/l/6/6/2, mean received dose intensity for 8p who completed 4 CT cycles; 0.76 (0.52-0.90). Major toxicity was hematologic; grade 314 toxicities in first CT cycle were; leukocytopenia in 47l6%, thrombocytopenia in 1816%. and in second CT cycle 13/l 3% and 20113% respectively. 13 p needed gCSF and 3 each platelet and/or RBC transfusion. Radiation esophagitis and pneumonitis were mild and infrequent (2 each cases of grade 2). Changes of PS score during treatment; -l/O/l = 1/8/l (data of 7 p were missing), mean weight loss; 2.1% (-5.2-8.6). Response rate; 88% (4 CRs, 11 PRs, 1 PD, 1 NE) with M duration of 11.6 mos. (2-27.6+). First site of relapse were; 4 in chest, 6 in brain and 2 in lymph node. With M follow up of 28.2 mos. (12.5-41) actual 1 yr. survival was 81% and actuarial 2 yr. survival was 41%. M survival time; 19.4 mos. (4.4-29.5). Conclusion: CE with concurrent TRT appear to be comparably effective to those cisplatin-based regimens and toxicities were relatively mild.
I259
Phase II trial of recombinant interleukin-4 (IL-4 SCH 39400) in advanced non-small cell lung cancer (NSCLC); A dose ranging study
M.R. Modiano ‘, S. Burdette-Radoux e, U. Gatzemeier 3, R.A. Figlin 4, S. Aamda15, J. Crawford6, M. Kies ‘, M.E. Rybake. ‘Ariz. C/in Res Cfr, USA, *McGill Uniy Canada, 3Krankenhaus Grosshansdod, Germany; 4UCLA, USA, 5Norwegian Radium Hasp, Norway, 6 Duke Univ; ‘Northwestern Univ, Chicago; s Schering-Plough Res lnst and the SPRI NSCLC Group, Kenilworth, NJ, USA IL-4 is a cytokine with antitumor activity in animal models and early clinical trials, IL-4 receptors are expressed on NSCLC and IL-4 synergizes with chemotherapy in animal tumor models. A multicenter (32 site), dose ranging study was conducted in 181 previously treated and untreated stage IIIB
and IV NSCLC pts or 8 (17 pts) p/kg were balanced for status was poorer mcglkg arm (81% 3-4 AE’s in 12% fatigue, headache
randomized to a dose of 1 (54 pts), 2 (56 pts), 4 (54 pts) IL-4 T.I.W. as monotherapy for 6 mos. Treatment arms age, stage, prior therapy and weight loss. Performance on the 1 mcg/kg arm with more PS 1 (vs 0) on the 1 vs 59-64%) PSl in the other treatment groups. Grade of pts. were dose related anorexia, nausea, vomiting, and dyspnea Activity is shown below.
Response Rate
Dose WI
CR+PR
l.O(N=54) 2.0 (N= 56) 4.0 (N = 54) 8.0 (N = 17)
6% 0% 4% 0%
SD
Survival z-300 d All Median
No Prior Rx
Median
30% 19% 19% 12%
33% 23% 20% 29%
43% 23% 20% 29%
372 d 193d 169d 159d
188d 1936 1584 194d
Conclusion: despite a modest response rate, a survival effect is comparable to current available therapy. The 1 mcg/kg dose may be superior, Follow-up is in progress.
260 L-l
Paclitaxel (Taxol@) and carboplatin followed by concomitant Taxol@, cisplatin and radiotherapy in stage IIIB NSCLC
O.-P. Isokangas, H. Joensuu, M. Halme, A. Jekunen, K. Mattson. Departments of Oncology and Int Medicine, Pulmonary Division, University Central Hospital, PIN-00290 Helsinki, Fin/and
Helsinki
The efficacy and toxicity of low-dose paclitaxel (Taxole) combined with carboplatin before RT, and with cisplatin during FIT, were assessed in Stage IIIB NSCLC. Induction CT consisted of Taxole (135 mg/m*) given on day 1 by 1 hr infusion, followed by carboplatin (200 mg/m*) on day 2 (30 min infusion). CT was repeated every 3 weeks for 3 cycles. Patients free of distant progression after induction chemotherapy received megavoltage radiation (56 Gy, 2 Gy/fraction) with 6- to -24 MV photons along with CDDP (30 ms/m*) and paclitaxel (30 ms/m*) given 2 to 4 hours before irradiation on days 1, 2 and 3 of cycles 4 and 5. Treatment planning CT scans were performed in all patients to obtain image data for beams-eye view planning of treatment portals. A combination of anteroposterior and posteroanterior and oblique treatment fields were used to limit the spinal cord-and the left heart dose to 36 Gy. The primary tumour and the ipsilateral hilus with mediastinum were encompassed with a 2 cm margin in the original volume. The bost volume included the primary tumor with 1 cm margine. Particular efforts were made to monitor side-effects using laboratory examinations, CT scans and lung function tests. to date, 27 patients have completed 3 cycles of induction CT, and 21 patients RT-Taxole-cisplatin-treatment. II I27 (40%) responded to 3 cycles of Garbo-Taxol and 19121 (90%) to the combined treatment with 9121 (42%) complete responders todate. Five cases of severe radiation pneumonitis and two cases of severe cytopenia during the second half of CT-RT were observed. We conclude that concurrent Taxol-cisplatin and RT produce a high response rate in NSCLC (IIIB) with moderate toxicity.
I261
Surgery & adjuvant chemotherapy lung cancer (SCLC)
R. Tsuchiya, Y. Watanabe, Oncology Group (JCOG),
T. Yasumitsu, Tokyo, Japan
Y. Ichinose.
(CT) for small cell Japanese
Clinical
Prospective single-arm study of surgical adjuvant chemotherapy for SCLC has been conducted. 61 patients with completely resecting SCLC of pathological stage I, II and llla were registered from Sep. 1991 until Dec. 1996. Among the cases of SCLC diagnosed before operation, only the cases of stage I and II were operated on. 6 patients were presumed as stage llla non-SCLC before operation and confirmed as SCLC by histological examination of surgical specimen after operation. Adjuvant chemotherapy was planned 4 courses of CDDP 100 mg/m2 on day 1 and VP-16 100 mg/m2 on day 1, 2 and 3. Treatment summary and patients caracteristics are as follows (registered before Jul 20, 1996);
I257
Result of extended resection of the left atrium, great vessels, or both for locally advanced lung cancer
Q.H. Zhou, L.X. Liu, Y. Wang, H.B. Zhang, J.J. Yang, Z.H. Yang. Department of Thoacocarrfiac Surgery; The first University Hospital West China University of Medical Sciences, Chengdu Sichuan 610041, PR China Lung cancer causes the first highest number of cancer-related death in China. But, only one third of patients with lung cancer can be identified as operative candidates. For the other two thirds is inoperable, because they have advanced lung cancer with distant metastasis or locally advanced lung cancer involving neighboring organs. Recently, introduction of the technique of cardiovascular surgery into lung cancer surgery has made possible en bloc resection of the lung combined with part of the involved left atrium, aorta, superior vena cava, and pulmonary artery. One hundred and ten patients with locally advanced lung cancer were admitted into our hospital from February, 1983 to May 1998. A single additional organ was resected in 93 patients, two organs in 14 patients and three organs in 3 cases. Of these patients, combined resection of the lung and left atrium was performed in 42 patients, the pulmonary artery in 82 cases, superior vena cava in 4, and aorta in 2. There was no operative death in this series. The 1 -year, 3-year, and 5year survival rate for all patients was 78.38%, 58.40%, and 35.81% respectively. The 5-year survival rate after left atrium resection was 33.33%. pulmonary artery resection and reconstruction was 38.1%, superior vena cava 25.0% and aorta 50.0% respectively. These results, therefore, suggest that extended resection of the left great vessels, or both was worthwhile for the patients with locally advanced lung cancer.
258 El
Concurrent hyperfractionated thoracic radiotherapy (TRT) with carboplatin and etoposide for the treatment of limited small cell lung cancer (LSCLC)
S. Koinumaru, J. Saito, Y. Nakai. Group, Sendai, Japan
Tohoku
Lung Cancer
Chemotherapy
We conducted a trial to evaluate the efficacy and toxicity of concurrent TRT with carboplatin (C)and etoposide (E) for LSCLC. TRT began from day 2 of first cycle of chemotherapy (CT); 1.5 Gy bid, 5 tiwk x 3 wk. CT consisted of C 300 mg/m* day 1 and E 80 m9/m’ day 1 to 5 q2ld x 4. Since 7’93, 21 patients (p) registered. As of 12’98, 17 p were fully evaluated. All were male, median (M) age; 88 (range; 46-79) PS; O/l/2 = SD/l, stage III A/III B = 918, mean TRT dose; 43.6 Gy (38.4-45.0), CT cycles: l/2/3/4/4+ = 2/l/6/6/2, mean received dose intensity for 8p who completed 4 CT cycles; 0.76 (0.52-0.90). Major toxicity was hematologic; grade 314 toxicities in first CT cycle were; leukocytopenia in 47l6%, thrombocytopenia in 1816%. and in second CT cycle 13/l 3% and 20113% respectively. 13 p needed gCSF and 3 each platelet and/or RBC transfusion. Radiation esophagitis and pneumonitis were mild and infrequent (2 each cases of grade 2). Changes of PS score during treatment; -l/O/l = 1/8/l (data of 7 p were missing), mean weight loss; 2.1% (-5.2-8.6). Response rate; 88% (4 CRs, 11 PRs, 1 PD, 1 NE) with M duration of 11.6 mos. (2-27.6+). First site of relapse were; 4 in chest, 6 in brain and 2 in lymph node. With M follow up of 28.2 mos. (12.5-41) actual 1 yr. survival was 81% and actuarial 2 yr. survival was 41%. M survival time; 19.4 mos. (4.4-29.5). Conclusion: CE with concurrent TRT appear to be comparably effective to those cisplatin-based regimens and toxicities were relatively mild.
I259
Phase II trial of recombinant interleukin-4 (IL-4 SCH 39400) in advanced non-small cell lung cancer (NSCLC); A dose ranging study
M.R. Modiano ‘, S. Burdette-Radoux e, U. Gatzemeier 3, R.A. Figlin 4, S. Aamda15, J. Crawford6, M. Kies ‘, M.E. Rybake. ‘Ariz. C/in Res Cfr, USA, *McGill Uniy Canada, 3Krankenhaus Grosshansdod, Germany; 4UCLA, USA, 5Norwegian Radium Hasp, Norway, 6 Duke Univ; ‘Northwestern Univ, Chicago; s Schering-Plough Res lnst and the SPRI NSCLC Group, Kenilworth, NJ, USA IL-4 is a cytokine with antitumor activity in animal models and early clinical trials, IL-4 receptors are expressed on NSCLC and IL-4 synergizes with chemotherapy in animal tumor models. A multicenter (32 site), dose ranging study was conducted in 181 previously treated and untreated stage IIIB
and IV NSCLC pts or 8 (17 pts) p/kg were balanced for status was poorer mcglkg arm (81% 3-4 AE’s in 12% fatigue, headache
randomized to a dose of 1 (54 pts), 2 (56 pts), 4 (54 pts) IL-4 T.I.W. as monotherapy for 6 mos. Treatment arms age, stage, prior therapy and weight loss. Performance on the 1 mcg/kg arm with more PS 1 (vs 0) on the 1 vs 59-64%) PSl in the other treatment groups. Grade of pts. were dose related anorexia, nausea, vomiting, and dyspnea Activity is shown below.
Response Rate
Dose WI
CR+PR
l.O(N=54) 2.0 (N= 56) 4.0 (N = 54) 8.0 (N = 17)
6% 0% 4% 0%
SD
Survival z-300 d All Median
No Prior Rx
Median
30% 19% 19% 12%
33% 23% 20% 29%
43% 23% 20% 29%
372 d 193d 169d 159d
188d 1936 1584 194d
Conclusion: despite a modest response rate, a survival effect is comparable to current available therapy. The 1 mcg/kg dose may be superior, Follow-up is in progress.
260 L-l
Paclitaxel (Taxol@) and carboplatin followed by concomitant Taxol@, cisplatin and radiotherapy in stage IIIB NSCLC
O.-P. Isokangas, H. Joensuu, M. Halme, A. Jekunen, K. Mattson. Departments of Oncology and Int Medicine, Pulmonary Division, University Central Hospital, PIN-00290 Helsinki, Fin/and
Helsinki
The efficacy and toxicity of low-dose paclitaxel (Taxole) combined with carboplatin before RT, and with cisplatin during FIT, were assessed in Stage IIIB NSCLC. Induction CT consisted of Taxole (135 mg/m*) given on day 1 by 1 hr infusion, followed by carboplatin (200 mg/m*) on day 2 (30 min infusion). CT was repeated every 3 weeks for 3 cycles. Patients free of distant progression after induction chemotherapy received megavoltage radiation (56 Gy, 2 Gy/fraction) with 6- to -24 MV photons along with CDDP (30 ms/m*) and paclitaxel (30 ms/m*) given 2 to 4 hours before irradiation on days 1, 2 and 3 of cycles 4 and 5. Treatment planning CT scans were performed in all patients to obtain image data for beams-eye view planning of treatment portals. A combination of anteroposterior and posteroanterior and oblique treatment fields were used to limit the spinal cord-and the left heart dose to 36 Gy. The primary tumour and the ipsilateral hilus with mediastinum were encompassed with a 2 cm margin in the original volume. The bost volume included the primary tumor with 1 cm margine. Particular efforts were made to monitor side-effects using laboratory examinations, CT scans and lung function tests. to date, 27 patients have completed 3 cycles of induction CT, and 21 patients RT-Taxole-cisplatin-treatment. II I27 (40%) responded to 3 cycles of Garbo-Taxol and 19121 (90%) to the combined treatment with 9121 (42%) complete responders todate. Five cases of severe radiation pneumonitis and two cases of severe cytopenia during the second half of CT-RT were observed. We conclude that concurrent Taxol-cisplatin and RT produce a high response rate in NSCLC (IIIB) with moderate toxicity.
I261
Surgery & adjuvant chemotherapy lung cancer (SCLC)
R. Tsuchiya, Y. Watanabe, Oncology Group (JCOG),
T. Yasumitsu, Tokyo, Japan
Y. Ichinose.
(CT) for small cell Japanese
Clinical
Prospective single-arm study of surgical adjuvant chemotherapy for SCLC has been conducted. 61 patients with completely resecting SCLC of pathological stage I, II and llla were registered from Sep. 1991 until Dec. 1996. Among the cases of SCLC diagnosed before operation, only the cases of stage I and II were operated on. 6 patients were presumed as stage llla non-SCLC before operation and confirmed as SCLC by histological examination of surgical specimen after operation. Adjuvant chemotherapy was planned 4 courses of CDDP 100 mg/m2 on day 1 and VP-16 100 mg/m2 on day 1, 2 and 3. Treatment summary and patients caracteristics are as follows (registered before Jul 20, 1996);