A Phase III trial of fludarabine, cyclophosphamide, and rituximab vs. pentostatin, cyclophosphamide, and rituximab in B-cell chronic lymphocytic leukemia.

BACKGROUND: Uncontrolled studies comparing pentostatin (P), cyclophosphamide (C), and rituximab (R) (PCR) to fludarabine plus C+R (FCR) suggest similar efficacy with fewer infectious complications with PCR. We compared FCR and PCR in previously-untreated or minimally-treated B-cell chronic lymphocytic leukemia (CLL). TREATMENT: FCR (F 20 mg/m(2) Days 1-5, C 600 mg/m(2) Day 1, R 375 mg/m(2) Day 1) (28-day cycles) or PCR (P 4 mg/m(2) Day 1, C 600 mg/m(2) Day 1, R 375 mg/m(2) Day 1) (21-day cycles). Dose 1 of R: 100 mg/m(2) was given on Day 8 Cycle 1 and the remainder on Day 9; in subsequent cycles the entire dose was given on Day 1. RESULTS: Ninety-two patients were randomly assigned to each group (N = 184). Groups were balanced; ~20% had received prior chemotherapy. The infection rate (FCR/PCR) was 31%/36%, the infective event rate was 38%/45%; 30 (35%)/37 (44%) patients were hospitalized; total hospitalization days was 271/404. 12 (14%)/6 (7%) patients achieved complete remissions (CR); the overall response rate (ORR) including CR+nodular PR (nPR)+PR was 59%/49%. Grade 3-4 treatment related AEs: neutropenia (69%/57%), leukopenia (34%/17%), thrombocytopenia (13%/6%). Grade 3-4 infections: febrile neutropenia (8%/6%), fever (2%/6%), infection (1%/3%), urinary tract infection (1%/0%), pneumonia (3%/1%), and sepsis (1%/2%); 5 deaths (1 FCR/4 PCR) were treatment-related. CONCLUSIONS: PCR and FCR have significant activity in CLL and can be given safely in the community setting despite significant toxicity. ORRs were lower than expected; the CR rate was higher (NS) with FCR. This trial did not demonstrate a lower infection rate with PCR.

Results of a Phase II study of weekly docetaxel and carboplatin in Stage IIIB (with effusion) or Stage IV non-small cell lung cancer patients age

This study explores if advanced NSCLC patients with ECOG PS 2 and age

Results of a phase II multicenter trial of single-agent gemcitabine in patients with relapsed or chemotherapy-refractory Hodgkin's lymphoma.

This study's objective was to determine the efficacy and safety of gemcitabine in patients with relapsed or chemotherapy-refractory Hodgkin's lymphoma (HL). Twenty-nine patients were enrolled. Eight of the first 10 patients received intravenous gemcitabine (1250 mg/m2) days 1, 8, and 15 every 4 weeks. Two patients withdrew consent before treatment. Because of toxicity, the remaining 19 patients received 1000 mg/m2 on days 1 and 8 every 3 weeks. Of the 29 treated patients, 16 (55.2%) were male, the median age was 43 years (range, 20.9-77.3), and 89.7% of them were white. Twelve patients (41.4%) had an Eastern Cooperative Oncology Group performance status (PS) of 0, 14 (48.3%) had a PS of 1, and 3 (10.3%) had a PS of 2. All patients had >/= 2 prior chemotherapy regimens. Eighteen patients (62%) had a relapse following bone marrow transplantation. Of 27 evaluable patients, 6 (22%) had partial response, 14 (52%) had stable disease, and 7 (26%) had progressive disease. The median time to progression for all patients was 6.4 months (range, 1.1-21.9). The median survival for all patients was 26.9 months (range, < 1-28.4). All patients have discontinued treatment because of disease progression or relapse. Grade >/= 3 toxicity occurred in 14 patients (48.3%): thrombocytopenia (33.3%), neutropenia (29.6%), anemia (7.4%), increased alanine aminotransferase, reduced cardiac function, and fever (3.7% for each event). This study confirms the activity of gemcitabine in relapsed and highly refractory HL. Dose and schedule may be modified in the future to optimize responses. As gemcitabine is active in highly refractory/relapsed HL, future studies should consider incorporating gemcitabine in combination regimens as first-line therapy for patients with high-risk HL.