Multimodal treatment with chemotherapy (CT), surgery (S) or radiation (R) and interferon-α (IFN) in...
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139 519 CISPLATIN (DDP) VERSUS DDP + MITOXANTRONE (MXO) FOR ADENOCARCINOMA OF THE LUNG (ACL). F.Denkmayr and M.Orthmann, Arbeitskreis Bronchuskarzi- nom, Austria, 5020 LKA Salzburg. In our previous study we were able to show clear supe- riority of DDP+MXO in combination when compared with MXO-monotherapy.The study presented is intended to test these combined therapy in contrast to single DDP- therapy.Patients with verified inqperable ACL were ran domised in regimen A (DDP 60 mg/m fractionated over 4 days) or regimen B (same DDP-therapy plus 15 mg/m2 MXO on day l).Repetition of therapies in 4 week periods up to tumor progression or intolerable side effects. At key date 1.4.1991 66 patients were selected for the study, 36 were used for this evaluation (31 males and 5 females, average age 60, performance status at onset of therapy WHO-grade I for 5, grade II for 16 and III for 15; stage MO in 16 cases, MI in 17, Mx in 3).No patients had previous systemic treatment. At key date 23/36 patients had died. Partial remission could be achieved for regimen A in l/19, for regimen B in 3/17 cases. Survival time for A : 10,7 weeks cave- rage), for B : 23,9. These difference is already signi ficant (p=O,O2). Toxicity of both regimens was low : only three cases of WHO-grade III occured in A+B. The final data will be presented and discussed. 521 Adjutant chemotherapy led to increased survival rate in radically operated patients with norrsmall cell lung cancer. A. Niiranen, S.Niitamo-Korhonen, S.Pyrhtinen, M.Kouri and A. van Assendelft. Department of Radiotherapy and Oncology, Helsinki University Central Hospital. Helsinki, Finland. 1 IO patients with stage I (WHO) non-small cell lung cancer underwent radical surgery during the period 1962-7. After operation the patients were randomized into two groups: those receiving adjuvant chemotherapy (6x cyclophosphamide 400 mg/m2,adriamycin 40 mg/&, cisplatin 40 mg/m2) and those receiving no active treatment. The aim of the study was to evaluate whether adjuvant chemotherapy in radically operated patients Improved their survival. 64 patients were randomized to receive chemotherapy and 56tothe control group.At present. 61% are alive in the chemotherapy group and 47% Inthe control group (p - 0.050). Patientswith Tl disease survived significantly longer than those with T3. but also within these subgroups survival time was significantly longer among those receiving chemotherapy than among the controls (p - 0.002). Those patients in the chemotherapy group who completed the planned treatment lived longer than those whose chemotherapy was discontinued (16 patients refused). Patients who underwent pulmonectomy had a poorer outcome than those with smaller operations (p - 0.002). Again, the T stage did not explain this difference. It appaars that patients wkh non-small cell carcinoma of the lung of stage I who were primarily radically operated do benefll from adjuvant chemotherapy. The chemotherapy applied in this was not well tolerated and caused refusals because of nausea and vomlting. 520 MULTIMODAL TREATMENT WITH CHEMOTHERAPY (CT), SURGERY (S) or RADIATION (R) AND INTERFERON-a (IFN) IN sc~c : a prospective multicenter study O.Kokron, Arbeitskreis Bronchuskarzinom,Austria, KH Lainz, A-1130 Wien The purpose of these study is evaluation of an inter- disciplinary approach for the treatment of SCLC, to test the feasibility in regional lung centers. Patients of all tumour stages, except cerebral metas- stases, and without previous treatment, received a primary chemotherapy (PC) using VP-16 (480 mg/m2 frac- tionated i.v.) and BCNU (120mg/m2 i.v.), repeated eve- ry three weeks three times. In operable cases surgical removal of tumour region followed, in inoperable cases with loco-regional extension radiation (R) is adminis- tered. In cases where both local therapies cannot be applied (pleural effusion, stage IV, refusal by pa- tient), secondary alternating chemotherapy (SC) was given with Epirubicin (90 mg/m2 i.v.) + Cyclophospha- mide (900 mg/m2i.v.) + Vincristine (2mg i.v.) every four weeks 6 times. The same SC used for patients after S and R. Ultimately, all responders (CR and PR) are administered IFN-U during 6 months as an remis- sion-sustaining therapy. With key date April lst,1991, 112 patients from 11 lung departements entered the study. 80 patients are evaluable, 34/BO have died. Median survival for all patients is 29,l weeks. As for the discrepancies bet- ween planed and actual therapeutic steps: PC received 100% of patients (BO/BO), S 12% (10/7B), R 61% (41/67) SC 83%(54/65),and IFN 48X(12/25). 522 A randomized study of VP-16kisplatinkhest RT * GM-CSF in Limited Stage Small Cell Lung Cancer (SCLC): Preliminary Results of a Southwest Oncology Group (SWOG) Study. PA Bunn, J Crowley, M Hazuka, R Tolley, R Livingston. U of Colo., Denver, CO and SWOG, Seattle, WA To determine whether GM-CSF could reduce neutropenia, leukopenia, infections, days in hospital, and other toxicities from combined therapy in limited stage SCLC, patients (pts.) were randomized to receive or not receive GM-CSF at 250 mcg/mz SC BID d4-18 for 6 chemotherapy cycles. Pts. received VP-16 (60 mg/mz IV dl-3), cisplatin (25 mg/m2 IV dl-3) and concurrent chest irradiation 45 Gy/25 fx. After the fust 3 chemotherapy cycles, the chemotherapy doses were reduced to VP-16 50 mg/m* IV dl-3 and cisplatin 40 mg/mz IV dl for 3 additional cycles. A planned interim analysis after 176 patients were entered between 5189 and 4191 showed: % Thrombo- cytopen~ Ann -*rade3 4 GM-CSF 38 26 NoGM-CSF 9 5 P <.ool 5%Granulo- cytopenia 96 LeJJkopenia % Infections zGrade3 4 zGrade3 4 zGrade3 27 11 28 10 8 44 17 5.5 14 1 .03 <.ool .03 _. _ . There was significantly increased thrombocytopema in pts. receiv- ing GM-CSF. While pts. receiving GM-CSF had a significant reduction in leukopenia and granulocytopenia, they had signifi- cantly more infections and days febrile. There were no significant differences in the number of days hospitalized or the number of days of antibiotics. Major differences from other trials are the low degree of grade 4 granulocytopenia and the inclusion of chest irradiation with GM-CSF. In conclusion, GM-CSF was associated with a significant reduction in leukopenia and granulocytopenia, but a significant increase in thrombocytopenia, infection and fe- brile days. The randomization to GM-CSF has been discontinued.
Transcript of Multimodal treatment with chemotherapy (CT), surgery (S) or radiation (R) and interferon-α (IFN) in...
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519
CISPLATIN (DDP) VERSUS DDP + MITOXANTRONE (MXO) FOR ADENOCARCINOMA OF THE LUNG (ACL).
F.Denkmayr and M.Orthmann, Arbeitskreis Bronchuskarzi- nom, Austria, 5020 LKA Salzburg.
In our previous study we were able to show clear supe- riority of DDP+MXO in combination when compared with MXO-monotherapy.The study presented is intended to test these combined therapy in contrast to single DDP- therapy.Patients with verified inqperable ACL were ran domised in regimen A (DDP 60 mg/m fractionated over 4 days) or regimen B (same DDP-therapy plus 15 mg/m2 MXO on day l).Repetition of therapies in 4 week periods up to tumor progression or intolerable side effects. At key date 1.4.1991 66 patients were selected for the study, 36 were used for this evaluation (31 males and 5 females, average age 60, performance status at onset of therapy WHO-grade I for 5, grade II for 16 and III for 15; stage MO in 16 cases, MI in 17, Mx in 3).No patients had previous systemic treatment. At key date 23/36 patients had died. Partial remission could be achieved for regimen A in l/19, for regimen B in 3/17 cases. Survival time for A : 10,7 weeks cave- rage), for B : 23,9. These difference is already signi ficant (p=O,O2). Toxicity of both regimens was low : only three cases of WHO-grade III occured in A+B. The final data will be presented and discussed.
521
Adjutant chemotherapy led to increased survival rate in radically operated patients with norrsmall cell lung cancer.
A. Niiranen, S.Niitamo-Korhonen, S.Pyrhtinen, M.Kouri and A. van Assendelft. Department of Radiotherapy and Oncology, Helsinki University Central Hospital. Helsinki, Finland.
1 IO patients with stage I (WHO) non-small cell lung cancer underwent radical surgery during the period 1962-7. After operation the patients were randomized into two groups: those receiving adjuvant chemotherapy (6x cyclophosphamide 400 mg/m2,adriamycin 40 mg/&, cisplatin 40 mg/m2) and those receiving no active treatment. The aim of the study was to evaluate whether adjuvant chemotherapy in radically operated patients Improved their survival. 64 patients were randomized to receive chemotherapy and 56tothe control group.At present. 61% are alive in the chemotherapy group and 47% In the control group (p - 0.050). Patients with Tl disease survived significantly longer than those with T3. but also within these subgroups survival time was significantly longer among those receiving chemotherapy than among the controls (p - 0.002). Those patients in the chemotherapy group who completed the planned treatment lived longer than those whose chemotherapy was discontinued (16 patients refused). Patients who underwent pulmonectomy had a poorer outcome than those with smaller operations (p - 0.002). Again, the T stage did not explain this difference. It appaars that patients wkh non-small cell carcinoma of the lung of stage I who were primarily radically operated do benefll from adjuvant chemotherapy. The chemotherapy applied in this was not well tolerated and caused refusals because of nausea and vomlting.
520
MULTIMODAL TREATMENT WITH CHEMOTHERAPY (CT), SURGERY (S) or RADIATION (R) AND INTERFERON-a (IFN) IN sc~c : a prospective multicenter study
O.Kokron, Arbeitskreis Bronchuskarzinom,Austria, KH Lainz, A-1130 Wien
The purpose of these study is evaluation of an inter- disciplinary approach for the treatment of SCLC, to test the feasibility in regional lung centers. Patients of all tumour stages, except cerebral metas- stases, and without previous treatment, received a primary chemotherapy (PC) using VP-16 (480 mg/m2 frac- tionated i.v.) and BCNU (120mg/m2 i.v.), repeated eve- ry three weeks three times. In operable cases surgical removal of tumour region followed, in inoperable cases with loco-regional extension radiation (R) is adminis- tered. In cases where both local therapies cannot be applied (pleural effusion, stage IV, refusal by pa- tient), secondary alternating chemotherapy (SC) was given with Epirubicin (90 mg/m2 i.v.) + Cyclophospha- mide (900 mg/m2i.v.) + Vincristine (2mg i.v.) every four weeks 6 times. The same SC used for patients after S and R. Ultimately, all responders (CR and PR) are administered IFN-U during 6 months as an remis- sion-sustaining therapy. With key date April lst,1991, 112 patients from 11 lung departements entered the study. 80 patients are evaluable, 34/BO have died. Median survival for all patients is 29,l weeks. As for the discrepancies bet- ween planed and actual therapeutic steps: PC received 100% of patients (BO/BO), S 12% (10/7B), R 61% (41/67) SC 83%(54/65),and IFN 48X(12/25).
522
A randomized study of VP-16kisplatinkhest RT * GM-CSF in Limited Stage Small Cell Lung Cancer (SCLC): Preliminary Results of a Southwest Oncology
Group (SWOG) Study. PA Bunn, J Crowley, M Hazuka, R Tolley, R Livingston. U of Colo., Denver, CO and SWOG, Seattle, WA
To determine whether GM-CSF could reduce neutropenia, leukopenia, infections, days in hospital, and other toxicities from combined therapy in limited stage SCLC, patients (pts.) were randomized to receive or not receive GM-CSF at 250 mcg/mz SC BID d4-18 for 6 chemotherapy cycles. Pts. received VP-16 (60 mg/mz IV dl-3), cisplatin (25 mg/m2 IV dl-3) and concurrent chest irradiation 45 Gy/25 fx. After the fust 3 chemotherapy cycles, the chemotherapy doses were reduced to VP-16 50 mg/m* IV dl-3 and cisplatin 40 mg/mz IV dl for 3 additional cycles. A planned interim analysis after 176 patients were entered between 5189 and 4191 showed:
% Thrombo- cytopen~
Ann -*rade3 4 GM-CSF 38 26 NoGM-CSF 9 5 P <.ool
5%Granulo- cytopenia 96 LeJJkopenia % Infections
zGrade3 4 zGrade3 4 zGrade3 27 11 28 10 8 44 17 5.5 14 1
.03 <.ool .03 _. _ . There was significantly increased thrombocytopema in pts. receiv- ing GM-CSF. While pts. receiving GM-CSF had a significant reduction in leukopenia and granulocytopenia, they had signifi- cantly more infections and days febrile. There were no significant differences in the number of days hospitalized or the number of days of antibiotics. Major differences from other trials are the low degree of grade 4 granulocytopenia and the inclusion of chest irradiation with GM-CSF. In conclusion, GM-CSF was associated with a significant reduction in leukopenia and granulocytopenia, but a significant increase in thrombocytopenia, infection and fe- brile days. The randomization to GM-CSF has been discontinued.
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