adverse effect of intrapleural corynebacterium parvum as adjuvant therapy in resected stage i and ii...

1
229 acceptable. Only four of the 119 treated cycles were followed by fever even though there was significant neutropenia (0.5 x i0 /i) after 20 of 97 treatment cycles. The majority of patients receiving BEP ex- perienced relief of cough, hemoptysis, pain, and fatique associated with their disease. There was a good correlation be- tween objective responses and palliation of symptoms. Thus, BEP offers good palli- ation, particularly for patients with squamous-cell and large-cell lung cancer. Doxorubicin, Cyclophosphamide, CCNU, and Vincristine With or Without Cisplatinum in Non-Small Cell Lung Cancer. Chlebowski, R.T., Herrold, J., Ali, I. et al. Division of Medical Oncology, Harbor -UCLA Medical Center, Torrance, CA 90509, U.S.A. Am. J. Clin. Oncol., Cancer Clin. Trials 8: 157-161, 1985. To evaluate the role of cisplatinum in the treatment of advanced non-small cell lung cancer, 48 patients received ~ither a doxorubicin (adriamycin~ 50 mg/m- i.v., cyclophosphamide 3002mg/m- i.v., lomu- stine (CCNU) 50 mg~m p.o., vincristine (oncovin) 1.2 mg/m i.v. (ACCO) combina- tion or2the same drugs plus cisplatinum 50 mg/m i.v. (PACCO) in a prospective sequential trial. No patient had received prior chemotherapy. Patients receiving the two regimens were comparable with regard to median age~performance status, histo- logic subtype, disease extent, and weight loss. Objective response frequency was only 5% in the initial 20 patients re- ceiving ACCO treatment compared to a re- sponse frequency of 28% (7% complete) in the 28 patients receiving cisplatinum in the PACCO treatment arm (p < 0.06). Patients achieving objective response li- ved significantly longer than nonrespon- ders (9.1 months vs. 3.8 months, p < 0.05). Although median survival was similar on the two regimens (6.1 months for ACCO vs. 7.6 months for PACCO), more than four times as many patients were alive after l year in the PACCO treatment group (24% vs. 5%). Predominant toxicity consisted of moderately severe nausea and vomiting (63% on PACCO vs. 34% on ACCO, p < 0.05)~ and myelosuppression with WBC < 3,000/mm- occurring in the majority of patients on both regimens. These results suggest cis- platinum addition to a doxorubicin, cyclo- phosphamide, lomustine, and vincristine combination may be associated with in- creased 1-year survival in the non-small cell lung cancer patient population. 8, RADIOTHERAPY Prophylactic Versus no Brain Irradiation in Regional Small Cell Lung Carcinoma. Seydel, H.G., Creech, R., Pagano, M. et al. Henry Ford Hospital, Detroit, MI 48202, U.S.A. Am. J. Clin. Oncol., Cancer Clin. Trials 8: 218-223, 1985. Among 104 complete responders entered in a ran- domized prospective trial of treatments for regio- nal small cell undifferentiated carcinoma of the lung, 52 received prophylactic irradiation of the brain, 3,000 tad in i0 fractions, and 52 did not. The median survivals were 53 and 52 weeks respec- tively, and the incidences of brain metastases were 5% and 20%. Prophylactic brain irradiation was not associated with significant long-term toxicity. Whole Brain Irradiation for Metastases from Lung Carcinoma: A Clinical Investigation. Chatani, M., Teshima, T., Hata, K. et al. Depart- ment of Radiation Therapy, The Center for Adult Diseases, Osaka 537, Japan. Acta. Radiol., Ser. Oncol. 24: 311-314, 1985. Sixty-nine consecutive patients with brain meta- stases from lung carcinoma were randomly allocated to one of the two radiation therapy schedules: 30 Gy/10 fractions/2 weeks or 50 Gy/20 fractions/4 weeks. The improvement rate for neurologic function was similar in the two groups. The median survival times for patients receiving the short course and the long course were 4 months and 3 months, respec- tively. The half-year survival rate was 42 per cent after the short course and 14 per cent after the long course (p < 0.05). Performance status and lac- tate dehydrogenase were other factors which signi- ficantly influenced the half-year survival rate. 9, COIVBINED TREATMENTMODALITIES Adverse Effect of Intrapleural Corynebacteri~n Pa1~a~n as Adjuvant Therapy in Resected Stage I and II Non-Small Cell Carcinoma of the Lung. Kaufmann, M., Stjernsward, J., Zimmermann, A. et al. Ludwig Institute for Cancer Research, Inselspital, 3010 Bern, Switzerland, J. Thorac. Cardiovasc. Surg. 89: 842-847, 1985. Intrapleural Corynebacterium parvum 7 mg or pla- cebo was administered postoperatively as adjuvant therapy to patients with resected Stage I and II non-small cell lung cancer in a prospective, rando- mized, multicenter trial. A total of 475 patients were entered into this study between July, 1977, and February, 1979. Of this group, 405 can be evalu- ated, with an average follow-up time of 4.6 years. More side effects, especially fever and chest pain, were observed in patients receiving Corynebacterium parvum (p < 0.001). An increase in fever was asso- ciated with a decrease in survival (p=0.01). Life- threatening or fatal complications were not seen. Important prognostic factors are surgical stage (p < 0.001) and degree of differentiation (p=0.02). Corynebacterium parvum is associated with a decrea- sed survival (p=0.02). It is concluded that intra- pleural Corynebacterium parvum is detrimental to survival. Combined ~bdality Therapy with Radiotherapy, Chemo- therapy, and I~nunotherapy in Limited Small-Cell

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Page 1: Adverse effect of intrapleural corynebacterium parvum as adjuvant therapy in resected stage I and II non-small cell carcinoma of the lung

229

acceptable. Only four of the 119 treated

cycles were followed by fever even though there was significant neutropenia (0.5 x i0 /i) after 20 of 97 treatment cycles. The majority of patients receiving BEP ex- perienced relief of cough, hemoptysis, pain, and fatique associated with their disease. There was a good correlation be- tween objective responses and palliation of symptoms. Thus, BEP offers good palli- ation, particularly for patients with squamous-cell and large-cell lung cancer.

Doxorubicin, Cyclophosphamide, CCNU, and Vincristine With or Without Cisplatinum in Non-Small Cell Lung Cancer. Chlebowski, R.T., Herrold, J., Ali, I. et al. Division of Medical Oncology, Harbor -UCLA Medical Center, Torrance, CA 90509, U.S.A. Am. J. Clin. Oncol., Cancer Clin. Trials 8: 157-161, 1985.

To evaluate the role of cisplatinum in the treatment of advanced non-small cell lung cancer, 48 patients received ~ither a doxorubicin (adriamycin~ 50 mg/m- i.v.,

cyclophosphamide 3002mg/m- i.v., lomu- stine (CCNU) 50 mg~m p.o., vincristine (oncovin) 1.2 mg/m i.v. (ACCO) combina- tion or2the same drugs plus cisplatinum 50 mg/m i.v. (PACCO) in a prospective sequential trial. No patient had received prior chemotherapy. Patients receiving the two regimens were comparable with regard to median age~performance status, histo- logic subtype, disease extent, and weight loss. Objective response frequency was only 5% in the initial 20 patients re- ceiving ACCO treatment compared to a re- sponse frequency of 28% (7% complete) in the 28 patients receiving cisplatinum in the PACCO treatment arm (p < 0.06). Patients achieving objective response li- ved significantly longer than nonrespon- ders (9.1 months vs. 3.8 months, p < 0.05). Although median survival was similar on the two regimens (6.1 months for ACCO vs. 7.6 months for PACCO), more than four times as many patients were alive after l year in the PACCO treatment group (24% vs. 5%). Predominant toxicity consisted of moderately severe nausea and vomiting (63% on PACCO vs. 34% on ACCO, p < 0.05)~ and myelosuppression with WBC < 3,000/mm- occurring in the majority of patients on both regimens. These results suggest cis- platinum addition to a doxorubicin, cyclo- phosphamide, lomustine, and vincristine combination may be associated with in- creased 1-year survival in the non-small cell lung cancer patient population.

8, RADIOTHERAPY

Prophylactic Versus no Brain Irradiation in Regional Small Cell Lung Carcinoma.

Seydel, H.G., Creech, R., Pagano, M. et al. Henry Ford Hospital, Detroit, MI 48202, U.S.A. Am. J. Clin. Oncol., Cancer Clin. Trials 8: 218-223, 1985.

Among 104 complete responders entered in a ran- domized prospective trial of treatments for regio- nal small cell undifferentiated carcinoma of the lung, 52 received prophylactic irradiation of the brain, 3,000 tad in i0 fractions, and 52 did not. The median survivals were 53 and 52 weeks respec- tively, and the incidences of brain metastases were 5% and 20%. Prophylactic brain irradiation was not associated with significant long-term toxicity.

Whole Brain Irradiation for Metastases from Lung Carcinoma: A Clinical Investigation. Chatani, M., Teshima, T., Hata, K. et al. Depart- ment of Radiation Therapy, The Center for Adult Diseases, Osaka 537, Japan. Acta. Radiol., Ser. Oncol. 24: 311-314, 1985.

Sixty-nine consecutive patients with brain meta- stases from lung carcinoma were randomly allocated to one of the two radiation therapy schedules: 30 Gy/10 fractions/2 weeks or 50 Gy/20 fractions/4 weeks. The improvement rate for neurologic function was similar in the two groups. The median survival

times for patients receiving the short course and the long course were 4 months and 3 months, respec- tively. The half-year survival rate was 42 per cent after the short course and 14 per cent after the long course (p < 0.05). Performance status and lac- tate dehydrogenase were other factors which signi- ficantly influenced the half-year survival rate.

9, COIVBINED TREATMENT MODALITIES

Adverse Effect of Intrapleural Corynebacteri~n Pa1~a~n as Adjuvant Therapy in Resected Stage I and II Non-Small Cell Carcinoma of the Lung. Kaufmann, M., Stjernsward, J., Zimmermann, A. et al. Ludwig Institute for Cancer Research, Inselspital, 3010 Bern, Switzerland, J. Thorac. Cardiovasc. Surg. 89: 842-847, 1985.

Intrapleural Corynebacterium parvum 7 mg or pla- cebo was administered postoperatively as adjuvant therapy to patients with resected Stage I and II non-small cell lung cancer in a prospective, rando- mized, multicenter trial. A total of 475 patients were entered into this study between July, 1977, and February, 1979. Of this group, 405 can be evalu- ated, with an average follow-up time of 4.6 years. More side effects, especially fever and chest pain, were observed in patients receiving Corynebacterium parvum (p < 0.001). An increase in fever was asso- ciated with a decrease in survival (p=0.01). Life- threatening or fatal complications were not seen. Important prognostic factors are surgical stage (p < 0.001) and degree of differentiation (p=0.02). Corynebacterium parvum is associated with a decrea- sed survival (p=0.02). It is concluded that intra- pleural Corynebacterium parvum is detrimental to

survival.

Combined ~bdality Therapy with Radiotherapy, Chemo- therapy, and I~nunotherapy in Limited Small-Cell