Alemtuzumab + CHOP for Peripheral T Cell Lymphoma: Higher Remission, But Not Survival

Alemtuzumab + CHOP for Peripheral T Cell Lymphoma: Higher Remission, But Not Survival
Alemtuzumab + CHOP for Peripheral T Cell Lymphoma: Higher Remission, But Not Survival

CHICAGO — When added to the CHOP regimen, alemtuzumab increases remission rates in elderly patients with peripheral T cell lymphoma, final analysis of the international ACT-2 phase 3 trial presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting has shown.1

However, the addition of alemtuzumab did not improve event-free survival, progression-free survival, or overall survival, said Lorenz H. Trümper, MD, Georg-August University, Goettingen, Germany, presenting on behalf of the Deutsche Studiengruppe Hochmaligne Lymphome DSHNHL.

To date, standard treatment for peripheral T cell lymphoma remains unsatisfactory, due to high rates of early disease progression.

Between October 2007 and September 2013, the study randomly assigned 116 patients from 52 centers to receive either 6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; n = 58) or CHOP plus alemtuzumab, a monoclonal anti-CD52 antibody (n = 58), at 14-day intervals with G-CSF support. Patients received a total of alemtuzumab 360 mg until patient 39, when it was decreased to 120 mg.

“The protocol demanded stringent CMV/EBV monitoring and anti-infective prophylaxis,” he said. The study was powered to detect a 15% increase in event-free survival when alemtuzumab was added to CHOP.

Median patient age was 69 years (range, 60 to 80 years) and 58% were male. A total of 41% had angioimmunoblastic T cell lymphoma; 39%, peripheral T cell lymphoma not otherwise specified; 6%, anaplastic large cell lymphoma; and 14% had other subtypes.

Treatment as planned was administered in 79% of patients in the CHOP arm and 57% of the CHOP plus alemtuzumab arm. Grade 3/4 hematotoxicity was more frequent in the CHOP plus alemtuzumab arm: leukocytopenia grade 4 was 70% vs 54% in the CHOP arm, and thrombocytopenia grade 3/4 was 19% vs 13%, respectively. Infections were also higher in the CHOP plus alemtuzumab arm; 19 of 38 patients had viral infections (14 of which were CMV); 4 had fungal infections (including 1 Aspergillus); and 12 had bacterial infections, compared with no viral infections, 1 fungal infection, and 10 bacterial infections in the CHOP arm.

Complete remissions were achieved in 43% (95% CI, 30-57) of patients in the CHOP arm and 60% (95% CI, 47-73) in the CHOP plus alemtuzumab arm. Progressive disease occurred in 22% of patients in the CHOP arm and 16% in the CHOP plus alemtuzumab arm.

At 3 years, no significant differences were observed for event-free survival (23% for the CHOP arm and 26% for the CHOP plus alemtuzumab arm), progression-free survival (29% vs 26%), and overall survival (56% vs 38%).

Multivariate analysis for overall survival showed the most prominent risk factors to be bulky disease, defined as 7.5 cm (RR, 4.5; 95% CI, 2.2-9.2; P < .001), male gender (RR, 2.4; 95% CI, 1.4-4.4; P = .003), and ECOG > 1 (RR 2.0; 95% CI, 1.1-3.9; P = .034).

These data “provide a valuable dataset for planning of future trials,” he said. “Novel agents for the treatment of elderly patients with peripheral T cell lymphoma remains an urgent medical need,” Dr. Trümper concluded.

 

Reference

1. Trümper LH, Wulf G, Ziepert M, et al. Alemtuzumab added to CHOP for treatment of peripheral T-cell lymphoma (pTNHL) of the elderly: Final results of 116 patients treated in the international ACT-2 phase III trial. Oral presentation at: ASCO 2016 Annual Meeting; June 3-7, 2016; Chicago, IL.

Loading links....
You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs