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CALGB 50604: risk-adapted treatment of nonbulky early-stage Hodgkin lymphoma based on interim PET

David J. Straus, Sin-Ho Jung, Brandelyn Pitcher, Lale Kostakoglu, John C. Grecula, Eric D. Hsi, Heiko Schöder, Leslie L. Popplewell, Julie E. Chang, Craig H. Moskowitz, Nina Wagner-Johnston, John P. Leonard, Jonathan W. Friedberg, Brad S. Kahl, Bruce D. Cheson and Nancy L. Bartlett

Key Points

  • Interim PET nonbulky stage I/II patients had 3-year PFS of 91% with 4 ABVD cycles and no RT.

  • Too few patients were interim PET+ to draw firm conclusions about efficacy of escalated BEACOPP plus involved-field RT.

Abstract

A negative interim positron emission tomography/computerized tomography (PET/CT) after 1 to 3 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in patients with newly diagnosed, nonbulky stage I or II Hodgkin lymphoma (HL) predicts a low relapse rate. This phase 2 trial was designed to determine if a population of patients with early-stage disease can be treated with short-course ABVD without radiation therapy (RT) on the basis of a negative interim PET/CT, thereby limiting the risks of treatment. Between 15 May 2010 and 21 February 2013, 164 previously untreated patients with nonbulky stage I/II HL were enrolled, and 149 were included in the final analysis. Patients received 2 cycles of ABVD followed by PET. Deauville scores 1 to 3 were negative (≤ liver uptake) based on central review. PET patients received 2 more cycles of ABVD, and PET+ patients received 2 cycles of dose-intense bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (escalated BEACOPP) plus 3060-cGy involved-field RT. The primary objective was to determine 3-year progression-free survival (PFS) for the PET group. One hundred thirty-five patients (91%) were interim PET, and 14 patients (9%) were PET+. With median follow-up time of 3.8 years, the estimated 3-year PFS was 91% for the PET group and 66% for the PET+ group (hazard ratio, 3.84; 95% confidence interval, 1.50-9.84; P = .011). There was 1 death as a result of suicide. Four cycles of ABVD resulted in durable remissions for a majority of patients with early-stage nonbulky HL and a negative interim PET. This trial was registered at www.clinicaltrials.gov as #NCT01132807.

  • Submitted January 12, 2018.
  • Accepted June 20, 2018.
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