Doxorubicin, vinblastine, and gemcitabine (CALGB 50203) for stage I/II nonbulky Hodgkin lymphoma: pretreatment prognostic factors and interim PET

• Published in: Blood Vol. 117; no. 20; pp. 5314 - 5320
• Main Authors: Straus, David J., Johnson, Jeffrey L., LaCasce, Ann S., Bartlett, Nancy L., Kostakoglu, Lale, Hsi, Eric D., Schöder, Heiko, Hall, Nathan C., Jung, Sin-Ho, Canellos, George P., Schwartz, Lawrence H., Takvorian, Ronald W., Juweid, Malik E., Cheson, Bruce D.
• Format: Journal Article
• Language: English
• Published: Washington, DC Elsevier Inc 19.05.2011; Americain Society of Hematology; American Society of Hematology
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Biological and medical sciences; Clinical Trials and Observations; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Female; Hematologic and hematopoietic diseases; Hodgkin Disease - diagnostic imaging; Hodgkin Disease - drug therapy; Hodgkin Disease - pathology; Humans; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Lymphoid Neoplasia; Male; Medical sciences; Middle Aged; Neoplasm Staging; Positron-Emission Tomography; Prognosis; Remission Induction; Vinblastine - administration & dosage; Vinblastine - adverse effects; Young Adult; Radionuclide study; Antineoplastic agent; Prognosis; Gemcitabine; Early stage; Doxorubicin; Alkaloid; Isomerases; Lymphoproliferative syndrome; Pretreatment; Antimitotic; Pyrimidine nucleoside; DNA topoisomerase (ATP-hydrolysing); Vinblastine; Hematology; Enzyme; Enzyme inhibitor; Hodgkin disease; Malignant hemopathy; Topoisomerase II inhibitor; Lymphoma; Antimetabolic; Pyrimidine derivatives; Anthracyclins; Fluorine Organic compounds; Positron emission tomography; Cancer
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2010-10-314260

To reduce doxorubicin, bleomycin, vinblastine and dacarbazine toxicity, the Cancer and Leukemia Group B conducted a phase 2 trial of doxorubicin, vinblastine, and gemcitabine for newly diagnosed, nonbulky stages I and II Hodgkin lymphoma. Ninety-nine assessable patients received 6 cycles of doxorubicin 25 mg/m2, vinblastine 6 mg/m2, and gemcitabine 800 mg/m2 (1000 mg/m2 in first 6) on days 1 and 15 every 28 days. Computed tomography (CT) and positron emission tomography (PET) were performed before and after 2 and 6 cycles. Complete remission (CR)/CR unconfirmed was achieved in 72 of 99 patients (72.7%) and partial remission in 24 of 99 patients (24.2%). The CR rate was 81% when using PET criteria. Two patients have died of Hodgkin lymphoma progression. Median follow-up for nonprogressing patients is 3.3 years. The progression-free survival (PFS) at 3 years was 77% (95% confidence interval, 68%-84%). The relapse rate was less than 10% for patients with favorable prognostic factors. The 2-year PFS for cycle 2 PET-negative and -positive patients was 88% and 54%, respectively (P = .0009), compared with 89% and 27% for cycle 6 PET-negative and -positive patients (P = .0001). Although the CR rate and PFS were lower than anticipated, patients with favorable prognostic features had a low rate of relapse. Cycle 2 PET and cycle 6 PET were predictive of PFS. This clinical trial is registered at www.clinicaltrials.gov as #NCT00086801.