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Clinical Trial
. 2018 Sep 6;132(10):1013-1021.
doi: 10.1182/blood-2018-01-827246. Epub 2018 Jul 26.

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

David J Straus  1   2 , Sin-Ho Jung  3 , Brandelyn Pitcher  3 , Lale Kostakoglu  4 , John C Grecula  5 , Eric D Hsi  6 , Heiko Schöder  1   2 , Leslie L Popplewell  7 , Julie E Chang  8 , Craig H Moskowitz  1   2 , Nina Wagner-Johnston  9 , John P Leonard  2 , Jonathan W Friedberg  10 , Brad S Kahl  9 , Bruce D Cheson  11 , Nancy L Bartlett  9
Affiliations
Clinical Trial

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

David J Straus et al. Blood. .

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.

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Conflict of interest statement

Conflict-of-interest disclosure: The authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
CONSORT diagram. DLCO, carbon monoxide diffusing capacity.
Figure 2.
Figure 2.
PFS for interim PET− and PET+ patients.
Figure 3.
Figure 3.
PFS for patients according to interim PET Deauville scores 1 to 2 vs 3 to 5.
Figure 4.
Figure 4.
PFS for patients according to interim PET Deauville scores 1 to 2 vs 3 vs 4 to 5.
Figure 5.
Figure 5.
PFS for patients with stage I/IIA or I/IIB disease.
See this image and copyright information in PMC

References

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    1. Straus DJ, Portlock CS, Qin J, et al. . Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004;104(12):3483-3489. - PubMed
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    1. Radford J, Illidge T, Counsell N, et al. . Results of a trial of PET-directed therapy for early-stage Hodgkin’s lymphoma. N Engl J Med. 2015;372(17):1598-1607. - PubMed

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