TY - JOUR
T1 - CALGB 50604
T2 - Risk-adapted treatment of nonbulky early-stage Hodgkin lymphoma based on interim PET
AU - Straus, David J.
AU - Jung, Sin Ho
AU - Pitcher, Brandelyn
AU - Kostakoglu, Lale
AU - Grecula, John C.
AU - Hsi, Eric D.
AU - Schöder, Heiko
AU - Popplewell, Leslie L.
AU - Chang, Julie E.
AU - Moskowitz, Craig H.
AU - Wagner-Johnston, Nina
AU - Leonard, John P.
AU - Friedberg, Jonathan W.
AU - Kahl, Brad S.
AU - Cheson, Bruce D.
AU - Bartlett, Nancy L.
N1 - Funding Information:
This work was supported by the National Cancer Institute of the National Institutes of Health under Awards U10CA180821 and U10CA180820 (to the Alliance for Clinical Trials in Oncology); U10CA007968, U10CA077597, U10CA077651, U10CA077658, U10CA180791, U10CA180833, U10CA180850, and U10CA180799 (ECOG-ACRIN); and U10CA180888 (SWOG). Additional support was provided by the Lymphoma Foundation, Rob and Karen Schneider and the Louis Schneider and Harry Davis Memorial Trust, the Adam R. Spector Foundation, and the David R. and Patricia D. Atkinson Foundation and Mr and Mrs Ernest Dicker (D.J.S.).
Publisher Copyright:
© 2018 by The American Society of Hematology.
PY - 2018/9/6
Y1 - 2018/9/6
N2 - 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. PET2 patients received 2 more cycles of ABVD, and PET1 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 PET2 group. One hundred thirty-five patients (91%) were interim PET2, and 14 patients (9%) were PET1. With median follow-up time of 3.8 years, the estimated 3-year PFS was 91% for the PET2 group and 66% for the PET1 group (hazard ratio, 3.84; 95% confidence interval, 1.50-9.84; P 5 .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.
AB - 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. PET2 patients received 2 more cycles of ABVD, and PET1 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 PET2 group. One hundred thirty-five patients (91%) were interim PET2, and 14 patients (9%) were PET1. With median follow-up time of 3.8 years, the estimated 3-year PFS was 91% for the PET2 group and 66% for the PET1 group (hazard ratio, 3.84; 95% confidence interval, 1.50-9.84; P 5 .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.
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U2 - 10.1182/blood-2018-01-827246
DO - 10.1182/blood-2018-01-827246
M3 - Article
C2 - 30049811
AN - SCOPUS:85052873587
SN - 0006-4971
VL - 132
SP - 1013
EP - 1021
JO - Blood
JF - Blood
IS - 10
ER -