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. 2023 Feb 10;41(5):1023-1034.
doi: 10.1200/JCO.22.00947. Epub 2022 Oct 21.

Positron Emission Tomography-Adapted Therapy in Bulky Stage I/II Classic Hodgkin Lymphoma: CALGB 50801 (Alliance)

Ann S LaCasce  1 , Travis Dockter  2 , Amy S Ruppert  3 , Lale Kostakoglu  4 , Heiko Schöder  5 , Eric Hsi  6 , Jeffrey Bogart  7 , Bruce Cheson  8 , Nina Wagner-Johnston  9 , Jeremy Abramson  10 , Kristie Blum  11 , John P Leonard  12 , Nancy L Bartlett  9
Affiliations

Positron Emission Tomography-Adapted Therapy in Bulky Stage I/II Classic Hodgkin Lymphoma: CALGB 50801 (Alliance)

Ann S LaCasce et al. J Clin Oncol. .

Abstract

Purpose: Patients with bulky stage I/II classic Hodgkin lymphoma (cHL) are typically treated with chemotherapy followed by radiation. Late effects associated with radiotherapy include increased risk of second cancer and cardiovascular disease. We tested a positron emission tomography (PET)-adapted approach in patients with bulky, early-stage cHL, omitting radiotherapy in patients with interim PET-negative (PET-) disease and intensifying treatment in patients with PET-positive (PET+) disease.

Methods: Eligible patients with bulky disease (mass > 10 cm or 1/3 the maximum intrathoracic diameter on chest x-ray) received two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by interim fluorodeoxyglucose PET (PET2). Patients with PET2-, defined as 1-3 on the 5-point scale, received four additional cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine. Patients with PET2+ received four cycles of escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone followed by 30.6 Gy involved-field radiation.

Results: Of 94 evaluable patients, 53% were female with median age 30 years (range, 18-58 years). Eight-five (90%) had stage II disease, including 48 (51%) with stage IIB/IIBE. Seventy-eight (78%) were PET2- and 21 (22%) were PET2+. The predominant toxicity was neutropenia, with 9% of patients developing febrile neutropenia and one developing sepsis. The primary end point of 3-year progression-free survival (PFS) was 93.1% in PET2- and 89.7% in PET2+ patients. Three-year overall survival was 98.6% and 94.4%, respectively. The estimated hazard ratio comparing PFS of patients with PET2+ and patients with PET2- was 1.03 (85% upper bound 2.38) and was significantly less than the null hypothesis of 4.1 (one-sided P = .04).

Conclusion: Our study of PET-adapted therapy in bulky stage I/II cHL met its primary goal and was associated with an excellent 3-year PFS rate of 92.3% in all patients, with the majority being spared radiotherapy and exposure to intensified chemotherapy.

Trial registration: ClinicalTrials.gov NCT01118026.

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Conflict of interest statement

Positron Emission Tomography–Adapted Therapy in Bulky Stage I/II Classic Hodgkin Lymphoma: CALGB 50801 (Alliance)

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Figures

FIG 1.
FIG 1.
Flow diagram. ABVD, doxorubicin, bleomycin, vinblastine, and dacarbazine; DLCO, diffusion capacity of lung for carbon monoxide; escBEACOPP, bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone; IFRT, involved-field radiation therapy; PET2, positron emission tomography after two cycles of chemotherapy; PFS, progression-free survival.
FIG 2.
FIG 2.
PFS for interim PET– and PET+ patients. The PFS event summary (number of PFS events/total number of patients) as well as the 3-year PFS estimate and 95% CI are presented for the PET– (dashed red line) and PET+ (solid blue line) groups. PET, positron emission tomography; PFS, progression-free survival.
FIG 3.
FIG 3.
PFS for interim Deauville 5 PS 1/2 or 3 patients. The PFS event summary (number of PFS events/total number of patients) as well as the 3-year PFS estimate and 95% CI are presented for the 5 PS = 1/2 (solid blue line) and 3 (dashed red line) groups. PFS, progression-free survival; PS, point scale.
FIG 4.
FIG 4.
PFS for interim Deauville 5 PS 4 or 5 patients. The PFS event summary (number of PFS events/total number of patients) as well as the 3-year PFS estimate and 95% CI are presented for the 5 PS = 4 (solid blue line) and 5 (dashed red line) groups. PFS, progression-free survival; PS, point scale.
FIG 5.
FIG 5.
OS for interim PET+ and PET– patients. The OS event summary (number of OS events/total number of patients) as well as the 3-year OS estimate and 95% CI are presented for the PET+ (solid blue line) and PET– (dashed red line) groups. OS, overall survival; PET, positron emission tomography.
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