Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma

Prasanth Ganesan, R. Rajendranath, K. Kannan, V. Radhakrishnan, T. S. Ganesan, K. Udupa, K. M. Lakshmipathy, V. Mahajan, S. Sundersingh, S. Rajaraman, R. Krishnakumar, T. G. Sagar

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Abstract

Background: Combination chemotherapy ABVD (doxorubicin, bleomycin, vinblastine and dacarabazine) cures ~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.

Original languageEnglish
Pages (from-to)1170-1174
Number of pages5
JournalAnnals of Oncology
Volume26
Issue number6
DOIs
Publication statusPublished - 01-01-2015

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Hodgkin Disease
Positron-Emission Tomography
Tomography
Disease-Free Survival
Therapeutics
Bleomycin
Doxorubicin
Procarbazine
Survival
Vinblastine
Poisons
Vincristine
Etoposide
Prednisolone
Combination Drug Therapy
Sample Size
Cyclophosphamide

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Ganesan, P., Rajendranath, R., Kannan, K., Radhakrishnan, V., Ganesan, T. S., Udupa, K., ... Sagar, T. G. (2015). Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma. Annals of Oncology, 26(6), 1170-1174. https://doi.org/10.1093/annonc/mdv077
Ganesan, Prasanth ; Rajendranath, R. ; Kannan, K. ; Radhakrishnan, V. ; Ganesan, T. S. ; Udupa, K. ; Lakshmipathy, K. M. ; Mahajan, V. ; Sundersingh, S. ; Rajaraman, S. ; Krishnakumar, R. ; Sagar, T. G. / Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma. In: Annals of Oncology. 2015 ; Vol. 26, No. 6. pp. 1170-1174.
@article{fed794f7a0874d1a8db6e5decc1c50e5,
title = "Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma",
abstract = "Background: Combination chemotherapy ABVD (doxorubicin, bleomycin, vinblastine and dacarabazine) cures ~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.",
author = "Prasanth Ganesan and R. Rajendranath and K. Kannan and V. Radhakrishnan and Ganesan, {T. S.} and K. Udupa and Lakshmipathy, {K. M.} and V. Mahajan and S. Sundersingh and S. Rajaraman and R. Krishnakumar and Sagar, {T. G.}",
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Ganesan, P, Rajendranath, R, Kannan, K, Radhakrishnan, V, Ganesan, TS, Udupa, K, Lakshmipathy, KM, Mahajan, V, Sundersingh, S, Rajaraman, S, Krishnakumar, R & Sagar, TG 2015, 'Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma', Annals of Oncology, vol. 26, no. 6, pp. 1170-1174. https://doi.org/10.1093/annonc/mdv077

Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma. / Ganesan, Prasanth; Rajendranath, R.; Kannan, K.; Radhakrishnan, V.; Ganesan, T. S.; Udupa, K.; Lakshmipathy, K. M.; Mahajan, V.; Sundersingh, S.; Rajaraman, S.; Krishnakumar, R.; Sagar, T. G.

In: Annals of Oncology, Vol. 26, No. 6, 01.01.2015, p. 1170-1174.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II study of interim PET-CT-guided responseadapted therapy in advanced Hodgkin's lymphoma

AU - Ganesan, Prasanth

AU - Rajendranath, R.

AU - Kannan, K.

AU - Radhakrishnan, V.

AU - Ganesan, T. S.

AU - Udupa, K.

AU - Lakshmipathy, K. M.

AU - Mahajan, V.

AU - Sundersingh, S.

AU - Rajaraman, S.

AU - Krishnakumar, R.

AU - Sagar, T. G.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Background: Combination chemotherapy ABVD (doxorubicin, bleomycin, vinblastine and dacarabazine) cures ~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.

AB - Background: Combination chemotherapy ABVD (doxorubicin, bleomycin, vinblastine and dacarabazine) cures ~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.

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DO - 10.1093/annonc/mdv077

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