1
63 survival (ES) (> than 12 mo) was found in 6/24 (25,19,18,15+,14,13+ mo) while 7/24 had a short survival (SS) (< 1 mo). ES pa- tients had an average ECOG performance status (PS) of 1.3 with none > 2 while SS patients had an average PS of 2.9. 2/6 ES patients had brain as the only site of me- tastases while 2/6 also had bone marrow metastases and 2/6 had bone metastases. SS patients had an average of 6.6 sites of metastases with liver involvement in 6/7. Treatment in ES patients consisted of 3500 to 3600 rads of whole brain radio- therapy (RT) as well as cyclophosphamide based on combination chemotherapy and RT to the primary lung lesion. Because of their rapid demise only 1 SS patient com- pleted cranial RT. 3/7 received no cranial RT and 5/7 received no chemotherapy. In conclusion, the prognosis of SCLC with brain metastases at diagnosis is extreme~ ly variable. Prolonged survival is possib- le in those patients with good PS and mini- mal extracranial metastases. Those patients with multiple sites of extracranial meta- stases (especially hepatic) and poor PS have a dismal prognosis, often not survi- ving initial attempts at treatment. A MultivariableAnalysis of Clinical Fac- tors Predictive of Survival in 406 Stage Ill Non-Small Cell Lung Cancer CNSCLC) Patients Treated with High-Dose Cisplatin/ Vinca Alkaloid Regimens. O'Connell, J., Kris, M., Gralla, R., Fiore, J., Heelan, R., Kelsen, D., Groshen, S., Berenson, M., Golbey, R. Memorial Sloan- Kettering Cancer Center, NY 10021, U.S.A. Performance status (PS), weight loss, presence of extrathoracic metastatic (met) disease, and involvement of specific met sites have been reported to be of progno- stic importance in NSCLC. To analyze the significance of these and other factors, data was prospectively collected on 406 patients (pts) with unresectable NSCLC treat- ed on 8 consecutive protocols from 1978- 85, all pts having PS>50, creatinine clea- rance > 6~ cc/min, and receiving cisplatin (120 mg/m )/vinca alkaloid containing re~ gimens. Pretreatment variables studied were: PS, age, histologic type of NSCLC, stage III MO va MI, number of met sites, presence of bone, brain, or liver mets, prior RT or surgery, weight loss, LDH, and sex. In univariate analysis, significant factors were: PS, sex, presence of extra- thoracic mets, more than one met site, bone mets, LDH and prior RT. Performing a multivariable analysis using the Cox pro- portional hazard model, survival was found to be adversely affected by: low PS(60-70) (median: 7.3 vs 12.4 mo, p < .001); male sex (8.8 vs 12.4 mo, p < .01); abnormal LDH (7.0 vs 14.0 mo, p < .001), and bone mets (6.5 vs ii mo, p = .001). When major re- Sponse to chemotherapy was included in this multivariate analysis, it was independently pre- dictive of prolongation of survival (17.8 va 6.4 mo, p < .01). We conclude: i) PS, sex, ab- normal LDH, and bone mets are significant prog- nostic factors in NSCLC; 2) major response to chemotherapy is an independent variable associ- ated with survival; and 3) design and report- ing of future chemotherapy trials should incor- porate data on these prognostic clinical vari- ables. Supported by CA-05862 and the Tishberg Fund. Clinical Characteristics of Patients with Sta- ge III Non-Small Cell Lung Cancer (NSCLC) re- ceiving Combination Chemotherapy. O'Connell, J., Kris, M., Gralla, R., Fiore, J., Heelan, R., Kelsen, D., Groshen, S., Berenson, M. Memorial Sloan-Kettering Cancer Center, New York, NY 10021, U.S.A. Data from all patients (pts) entered at our institution from 1978-1984 on 8 consecutive chemotherapy protocols were reviewed to compa- re the clinical characteristics of our pts to prior large series (Green, Cancer 28: 1229, 1971; Lanzotti, Cancer 39: 303, 1977; Stanley, JNCI 65: 25, 1980). There were 406 patients with proven stage III NSCLC, performance sta- tus > 50%, creatinine clearance > 659cc/min, and treated with cisplatin (120 mg/m-)/vinca alkaloid containing regimens. Median age was 55, there were 69% males and 31% females. Hi- stologic diagnoses included 67% adenocarcinoma, 25% epidermoid, and 8% large cell. Eighteen percent had localized, but unresectable, dis- ease and 82% extrathoracic metastatic disease; this included 28% with bone metastasis (met), 10% with brain mets and 8% with liver mets. One-third of the group had more than one met site. Weight loss > 5% was present in 40% of pts. The median LDH was 233 (normal < 230). Conclusions regarding this group of pts with unresectable NSCLC are: i) there are more fe- males and a younger age distribution than pre- viously reported; 2) adenocarcinoma is now the most frequent histologic type in contrast to some earlier studies and surgical series; 3) approximately two-thirds of pts with unresec- table disease do not have more than a single identified met site; 4) bone mets are more com- mon than liver or brain met; and 5) earlier stu- dies on the prognostic importance of clinical variables in unresectable NSCLC may not be ap- plicable to the population undergoing combina- tion chemotherapy in which the distribution of these variables may differ. Supported by CA- 05826 and the Tishberg Fund. Correlation of Cell Type and Sites of Metasta- ses iniWomen With LunR Cancer. 2 Skoseyi, C., Hoffman 2 P'' Ferguson-, M.K., Golomb 2 H.M., Little , A.G., Bitran, J., Skinner , D.B. ~e Univers~tM of Chlcag~,iDe- partments of i. Medicine, 2. Surgery, D~4

A multivariable analysis of clinical factors predictive of survival in 406 stage III non-small cell lung cancer (NSCLC) patients treated with high-dose cisplatin/vinca alkaloid regimens

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Page 1: A multivariable analysis of clinical factors predictive of survival in 406 stage III non-small cell lung cancer (NSCLC) patients treated with high-dose cisplatin/vinca alkaloid regimens

63

survival (ES) (> than 12 mo) was found in 6/24 (25,19,18,15+,14,13+ mo) while 7/24

had a short survival (SS) (< 1 mo). ES pa- tients had an average ECOG performance status (PS) of 1.3 with none > 2 while SS patients had an average PS of 2.9. 2/6 ES patients had brain as the only site of me- tastases while 2/6 also had bone marrow metastases and 2/6 had bone metastases. SS patients had an average of 6.6 sites of metastases with liver involvement in 6/7. Treatment in ES patients consisted of 3500 to 3600 rads of whole brain radio- therapy (RT) as well as cyclophosphamide based on combination chemotherapy and RT to the primary lung lesion. Because of their rapid demise only 1 SS patient com- pleted cranial RT. 3/7 received no cranial RT and 5/7 received no chemotherapy. In conclusion, the prognosis of SCLC with brain metastases at diagnosis is extreme~ ly variable. Prolonged survival is possib- le in those patients with good PS and mini- mal extracranial metastases. Those patients with multiple sites of extracranial meta- stases (especially hepatic) and poor PS have a dismal prognosis, often not survi- ving initial attempts at treatment.

A MultivariableAnalysis of Clinical Fac- tors Predictive of Survival in 406 Stage Ill Non-Small Cell Lung Cancer CNSCLC) Patients Treated with High-Dose Cisplatin/ Vinca Alkaloid Regimens. O'Connell, J., Kris, M., Gralla, R., Fiore, J., Heelan, R., Kelsen, D., Groshen, S., Berenson, M., Golbey, R. Memorial Sloan- Kettering Cancer Center, NY 10021, U.S.A.

Performance status (PS), weight loss, presence of extrathoracic metastatic (met) disease, and involvement of specific met sites have been reported to be of progno- stic importance in NSCLC. To analyze the significance of these and other factors, data was prospectively collected on 406 patients (pts) with unresectable NSCLC treat- ed on 8 consecutive protocols from 1978- 85, all pts having PS>50, creatinine clea- rance > 6~ cc/min, and receiving cisplatin (120 mg/m )/vinca alkaloid containing re~ gimens. Pretreatment variables studied were: PS, age, histologic type of NSCLC, stage III MO va MI, number of met sites, presence of bone, brain, or liver mets, prior RT or surgery, weight loss, LDH, and sex. In univariate analysis, significant factors were: PS, sex, presence of extra- thoracic mets, more than one met site, bone mets, LDH and prior RT. Performing a multivariable analysis using the Cox pro- portional hazard model, survival was found to be adversely affected by: low PS(60-70) (median: 7.3 vs 12.4 mo, p < .001); male sex (8.8 vs 12.4 mo, p < .01); abnormal

LDH (7.0 vs 14.0 mo, p < .001), and bone

mets (6.5 vs ii mo, p = .001). When major re- Sponse to chemotherapy was included in this

multivariate analysis, it was independently pre- dictive of prolongation of survival (17.8 va 6.4 mo, p < .01). We conclude: i) PS, sex, ab- normal LDH, and bone mets are significant prog- nostic factors in NSCLC; 2) major response to chemotherapy is an independent variable associ- ated with survival; and 3) design and report- ing of future chemotherapy trials should incor- porate data on these prognostic clinical vari- ables. Supported by CA-05862 and the Tishberg Fund.

Clinical Characteristics of Patients with Sta- ge III Non-Small Cell Lung Cancer (NSCLC) re- ceiving Combination Chemotherapy. O'Connell, J., Kris, M., Gralla, R., Fiore, J., Heelan, R., Kelsen, D., Groshen, S., Berenson, M. Memorial Sloan-Kettering Cancer Center, New York, NY 10021, U.S.A.

Data from all patients (pts) entered at our institution from 1978-1984 on 8 consecutive chemotherapy protocols were reviewed to compa- re the clinical characteristics of our pts to prior large series (Green, Cancer 28: 1229, 1971; Lanzotti, Cancer 39: 303, 1977; Stanley, JNCI 65: 25, 1980). There were 406 patients with proven stage III NSCLC, performance sta- tus > 50%, creatinine clearance > 659cc/min, and treated with cisplatin (120 mg/m-)/vinca alkaloid containing regimens. Median age was 55, there were 69% males and 31% females. Hi- stologic diagnoses included 67% adenocarcinoma, 25% epidermoid, and 8% large cell. Eighteen percent had localized, but unresectable, dis- ease and 82% extrathoracic metastatic disease; this included 28% with bone metastasis (met), 10% with brain mets and 8% with liver mets.

One-third of the group had more than one met site. Weight loss > 5% was present in 40% of pts. The median LDH was 233 (normal < 230). Conclusions regarding this group of pts with unresectable NSCLC are: i) there are more fe- males and a younger age distribution than pre- viously reported; 2) adenocarcinoma is now the most frequent histologic type in contrast to some earlier studies and surgical series; 3) approximately two-thirds of pts with unresec- table disease do not have more than a single identified met site; 4) bone mets are more com- mon than liver or brain met; and 5) earlier stu- dies on the prognostic importance of clinical variables in unresectable NSCLC may not be ap- plicable to the population undergoing combina- tion chemotherapy in which the distribution of these variables may differ. Supported by CA- 05826 and the Tishberg Fund.

Correlation of Cell Type and Sites of Metasta- ses iniWomen With LunR Cancer. 2 Skoseyi, C., Hoffman 2 P'' Ferguson-, M.K., Golomb 2 H.M., Little , A.G., Bitran, J.,

Skinner , D.B. ~e Univers~tM of Chlcag~,iDe- partments of i. Medicine, 2. Surgery, D~4