Phase Ii Trial Of Gemcitabine/Carboplatin (Gc) Followed By Paclitaxel (P) In Patients With Performance Status=2,3 Or Other Significant Co-Morbidity (Hiv Infection Or S/P Organ Transplantation) In Advanced Non-Small Cell Lung Cancer (Nsclc)

7661 Introduction: The role of chemotherapy (Rx) in patients (pts) with advanced NSCLC and poor performance status (PPS) defined as PS = 2 or 3 is unclear. While survival appears to be enhanced, serious toxicity may occur. In addition, no treatment options have been defined for the growing population of pts with HIV infection or post organ transplantation. Based on a prior study (Cancer 2001;92:146–152), we evaluated the efficacy of sequential, dose attenuated GC followed by P in patients with PS=2,3, HIV infection or s/p solid organ transplantation. Patients and Methods: Rx naive patients with PPS and adequate organ function received G: 1,000 mg/m2 d 1,8 C: AUC=5 d 1 q 21d × 2 followed by P 80 mg/m2 q wk × 6 followed by a 2 wk break and then repeated until progression. Results: 47 of a projected 47 pts have been enrolled. Stage IIIb/IV: 8/39, PS 2/3= 26/19, HIV infection=2, solid organ transplantation=2. 12 (25%) had brain metastases. Thirty-nine pts completed two cycles of GC and 29 pts received at least one cycle of P. Overall response rate:19% (95% CI 1.2%-31.7%). Median survival: 5.8 mo. One year survival: 8.4%. Median event free survival: 3.3 months. Toxicity rates for GC: Grade (gr) 3 neutropenia, anemia and thrombocytopenia = 29.8%, 14.9%, 23.4% respectively, gr 4 neutropenia=19% and 10.6% had gr 4 thrombocytopenia. There were 2 gr 1 bleeding episodes, two pts received platelets and 8 pts received red cells. 8.5% had gr 3 fatigue and 10.6% had gr 3 febrile neutropenia, 4.3% had grade 3 nausea, vomiting. Gr 4 nonhematologic toxicities: Thromboembolism = 1 pt (2.1%), Fever = 1 (2.1%). Toxicity rates for P phase: 2.1% had gr 3 neutropenia and anemia. 4.3% had gr 3 neuropathy. There was 1 episode of gr 4 hemoptysis. Two patients received red cells. Conclusions: 1) Sequential GC to P is well tolerated and active in this population. 2) Survival is comparable to that of other regimens utilized in PS = 2 pts with superior tolerability. 3) The prognosis for these pts is very poor even with Rx.4. This is the first trial to prospectively evaluate Rx for pts with HIV disease or organ transplantation and NSCLC. Supported by Bristol Myers Squibb. No significant financial relationships to disclose.