PMID- 25701453 OWN - NLM STAT- MEDLINE DCOM- 20160513 LR - 20240229 IS - 1569-8041 (Electronic) IS - 0923-7534 (Linking) VI - 26 IP - 6 DP - 2015 Jun TI - Phase II study of interim PET-CT-guided response-adapted therapy in advanced Hodgkin's lymphoma. PG - 1170-1174 LID - S0923-7534(19)31794-6 [pii] LID - 10.1093/annonc/mdv077 [doi] AB - BACKGROUND: Combination chemotherapy ABVD (doxorubicin, bleomycin, vinblastine and dacarabazine) cures approximately 70% of patients with advanced Hodgkin's lymphoma (aHL, stages IIB, III and IV) while more toxic escalated BEACOPP (EB, combination of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisolone) increases cure rates to 85%. Patients with a positive interim positron emission tomography-computerized tomography (PET-CT) scan after two cycles (PET-2) of ABVD have very poor outcomes with continued ABVD. Intensifying therapy with EB in PET-2-positive patients ('response-adapted therapy') may improve cure rates, whereas the negative patients can continue ABVD alone. PATIENTS AND METHODS: Eligible patients with newly diagnosed aHL received two cycles of ABVD and underwent PET-2 (scored with semi-quantitative 5-point visual criteria, 'Deauville score'). PET-2-negative patients continued four additional cycles of ABVD, whereas PET-2-positive patients received four cycles of EB. A phase II sample size of 50 was estimated keeping the lower and higher proportion of rejection of the event-free survival (EFS) as 70% and 85%, respectively. RESULTS: Fifty patients [median age 28 (12-60) years; male : female: 39 : 11; stages: IIB-3 (6%), III-29 (58%) and IV-18 (36%); International Prognostic Score (IPS): 0-3: 34 (68%); 4-7: 16 (32%)] were enrolled; 49 underwent PET-2. Eight (16%) were PET-2-positive, whereas 41 (84%) were negative. Forty-seven were evaluable for EFS and all 50 for overall survival (OS). The 2-year EFS was 76% (95% CI: 68-83) and OS was 88% (95% CI: 82-94). PET-2 was strongly prognostic-2-year EFS, negative versus positive: 82% versus 50%; P = 0.013. CONCLUSION: PET-2 response-adapted strategy could not achieve EFS of 85% in aHL. However, escalated therapy improved outcomes in PET-2-positive patients compared with historical data. TRIAL REGISTRATION: CTRI/2012/06/002741 (http://www.ctri.nic.in) and NCT01304849 (http://www.clinicaltrials.gov). CI - (c) The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. FAU - Ganesan, P AU - Ganesan P AD - Department of Medical Oncology. Electronic address: prasanth.ganesan@cancerinstitutewia.org. FAU - Rajendranath, R AU - Rajendranath R AD - Department of Medical Oncology. FAU - Kannan, K AU - Kannan K AD - Department of Medical Oncology. FAU - Radhakrishnan, V AU - Radhakrishnan V AD - Department of Medical Oncology. FAU - Ganesan, T S AU - Ganesan TS AD - Department of Medical Oncology. FAU - Udupa, K AU - Udupa K AD - Department of Medical Oncology. FAU - Lakshmipathy, K M AU - Lakshmipathy KM AD - Department of PET-CT Scan Center. FAU - Mahajan, V AU - Mahajan V AD - Department of Radiodiagnosis. FAU - Sundersingh, S AU - Sundersingh S AD - Department of Pathology. FAU - Rajaraman, S AU - Rajaraman S AD - Department of Tumor Registry, Cancer Institute (WIA), Chennai, India. FAU - Krishnakumar, R AU - Krishnakumar R AD - Department of Nuclear Medicine. FAU - Sagar, T G AU - Sagar TG AD - Department of Medical Oncology. LA - eng SI - CTRI/CTRI/2012/06/002741 SI - ClinicalTrials.gov/NCT01304849 PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20150220 PL - England TA - Ann Oncol JT - Annals of oncology : official journal of the European Society for Medical Oncology JID - 9007735 RN - 11056-06-7 (Bleomycin) RN - 35S93Y190K (Procarbazine) RN - 5J49Q6B70F (Vincristine) RN - 5V9KLZ54CY (Vinblastine) RN - 6PLQ3CP4P3 (Etoposide) RN - 7GR28W0FJI (Dacarbazine) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) RN - VB0R961HZT (Prednisone) RN - ABVD protocol RN - BEACOPP protocol SB - IM CIN - Ann Oncol. 2015 Jun;26(6):1045-7. PMID: 26003616 MH - Adolescent MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Bleomycin/administration & dosage/adverse effects MH - Child MH - Cyclophosphamide/administration & dosage/adverse effects MH - Dacarbazine/administration & dosage/adverse effects MH - Disease Progression MH - Disease-Free Survival MH - Doxorubicin/administration & dosage/adverse effects MH - Etoposide/administration & dosage/adverse effects MH - Female MH - Hodgkin Disease/diagnostic imaging/*drug therapy MH - Humans MH - India MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Multimodal Imaging MH - Neoplasm Staging MH - *Positron-Emission Tomography MH - Predictive Value of Tests MH - Prednisone/administration & dosage/adverse effects MH - Procarbazine/administration & dosage/adverse effects MH - Prospective Studies MH - Risk Factors MH - Time Factors MH - *Tomography, X-Ray Computed MH - Treatment Outcome MH - Vinblastine/administration & dosage/adverse effects MH - Vincristine/administration & dosage/adverse effects MH - Young Adult OTO - NOTNLM OT - ABVD OT - Deauville score OT - Hodgkin's lymphoma OT - escalated BEACOPP OT - interim PET-CT scan OT - response-adapted therapy EDAT- 2015/02/24 06:00 MHDA- 2016/05/14 06:00 CRDT- 2015/02/22 06:00 PHST- 2014/10/31 00:00 [received] PHST- 2015/02/09 00:00 [accepted] PHST- 2015/02/22 06:00 [entrez] PHST- 2015/02/24 06:00 [pubmed] PHST- 2016/05/14 06:00 [medline] AID - S0923-7534(19)31794-6 [pii] AID - 10.1093/annonc/mdv077 [doi] PST - ppublish SO - Ann Oncol. 2015 Jun;26(6):1170-1174. doi: 10.1093/annonc/mdv077. Epub 2015 Feb 20.