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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-negative non-bulky stage I/II patients have 91% 3-year PFS with 4 ABVD and no RT.

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

Abstract

Negative interim positron-emission tomography/ computerized tomography (PET/CT) following 1-3 cycles of doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) in newly diagnosed, non-bulky stage I and II Hodgkin lymphoma (HL) patients predicts a low relapse rate. This phase 2 trial was designed to determine if a population of early stage patients 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 5/15/10 and 2/21/13, 164 previously untreated patients with non-bulky stages I/II HL were enrolled, and 149 were included in the final analysis. Patients received 2 cycles of ABVD followed by PET. Deauville scores 1-3 were negative (≤ liver uptake), based on central review. PET-negative patients received 2 more cycles of ABVD, and PET-positive pts received 2 cycles of dose-intense bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (escalated BEACOPP) + 3060 cGy involved-field radiation therapy (IF RT). The primary objective was to determine the 3-year progression free survival (PFS) for the PET- negative group. One hundred thirty-five patients (91%) were interim PET-negative, and 14 patients (9%) were PET-positive. With median follow-up time of 3.8 years, the estimated 3-year PFS was 91% for the PET-negative group and 66% for the PET-positive group (p=0.011), hazard ratio 3.84 [1.50, 9.84]). There was 1 death from suicide. Four cycles of ABVD results in durable remissions for the majority of patients with early stage non-bulky HL and a negative interim PET. The study is registered to clinicaltrials.gov as NCT01132807.

  • Submitted January 16, 2018.
  • Accepted June 20, 2018.