Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials

Böll, Boris; Goergen, Helen; Behringer, Karolin; Bröckelmann, Paul J.; Hitz, Felicitas; Kerkhoff, Andrea; Greil, Richard; Tresckow, Bastian von; Eichenauer, Dennis A.; Bürkle, Carolin; Borchmann, Sven; Fuchs, Michael; Diehl, Volker; Engert, Andreas; Borchmann, Peter

doi:10.1182/blood-2015-11-681064

Cited by 100 publications

(70 citation statements)

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“…Pulmonary toxicity is a known of side effect of bleomycin and radiation involving the mediastinum and lung fields. [16][17][18][19] In addition, combining BV with the bleomycin-containing ABVD arm in the phase 1 study resulted in significant pulmonary toxicity, and, analogously, when SGN-30 (naked anti-CD30 monoclonal antibody) was combined with gemcitabine, severe grade 3 to 5 pneumonitis led to premature study closure. 14,20 We hypothesized that BV may be associated with subclinical pulmonary toxicity that is only unmasked when combined with an additional pulmonary insult, such as bleomycin or radiotherapy.…”

Section: Introductionmentioning

confidence: 99%

Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma

Kumar

Casulo

Yahalom

et al. 2016

Blood

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Key Points• BV and AVD followed by ISRT is well tolerated, without significant pulmonary toxicity. • BV and AVD followed by ISRT is an effective therapy for unfavorable-risk early stage HL, including bulky disease.This multicenter pilot study assessed the safety and efficacy of brentuximab vedotin (BV) and AVD (adriamycin, vinblastine, and dacarbazine) followed by 30 Gy involved site radiation therapy (ISRT). Patients with newly diagnosed, early stage classical Hodgkin lymphoma (HL) with unfavorable-risk features were treated with 4 cycles of BV and AVD.Patients who achieved a negative positron emission tomography (PET) scan (Deauville score of 1-3) received 30 Gy ISRT. Thirty patients received treatment and were assessable for toxicity. Twenty-nine patients completed 4 cycles of BV 1 AVD, and 25 patients BV 1 AVD 1 30 Gy ISRT. No clinically significant noninfectious pneumonitis was observed. Serious adverse events ( ‡grade 3) were reported in 4 patients, including febrile neutropenia, peripheral neuropathy, and hypertension. After 2 and 4 cycles of BV 1 AVD, 90% (26 of 29) and 93% (27 or 29) of patients achieved a negative PET scan, respectively. Two patients with biopsy-proven primary refractory HL were treated off-study. All 25 patients who completed BV 1 AVD 1 ISRT achieved a complete response. With a median follow-up of 18.8 months, by intent to treat, the 1-year progression-free survival is 93.3% (95% confidence interval, 84-102). Overall, the treatment was well-tolerated with no evidence of significant pulmonary toxicity. The majority of patients ( ‡90%) achieved negative interim PET scans after 2 and 4 cycles of BV 1 AVD. Excluding the 2 primary refractory patients, all patients are disease free, suggesting that this is a highly active treatment program even in patients with substantial disease bulk. This trial was

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Section: Introductionmentioning

confidence: 99%

Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma

Kumar

Casulo

Yahalom

et al. 2016

Blood

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“…A recent GHSG analysis found that increased BLT after four cycles of ABVD when compared to two cycles and hence omitting bleomycin after the second cycle is justified. In addition, patients with preexisting pulmonary comorbidity should not receive Bleomycin at all [94]. Numerous regimens such as PVAG (prednisone, vinblastine, doxorubicin, gemcitabine), BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, prednisone), or Stanford V were investigated to improve results in the elderly but were often more toxic, and no advantage over ABVD could be shown [93,95,96].…”

Section: Elderly Hl Patientsmentioning

confidence: 99%

The GHSG Approach to Treating Hodgkin’s Lymphoma

Bröckelmann

Engert

2015

Curr Hematol Malig Rep

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Hodgkin's lymphoma (HL) is a relatively rare disease accounting for 15 % of all lymphoma. This disease has developed from an incurable disease to the adult malignancy with the most favorable prognosis. With current therapeutic approaches consisting of polychemo- and small-field radiotherapy, up to 80 % of all patients can be cured long term. In refractory or relapsed HL, intensified treatment including high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is associated with progression-free survival (PFS) of 50 %. Evaluation of novel drugs in multiple relapsed or refractory cases, better treatment options for elderly patients and reducing treatment-related side effects are the main focus of current research. Recent clinical developments and future approaches in the treatment of HL will be discussed in this review.

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“…Сегодня активно обсуждается во-прос о возможности отказа от блеомицина без ущерба для эффективности терапии у больных ЛХ [15][16][17].…”

Section: Introductionunclassified

First-Line Therapy for Patients with Advanced Hodgkin’s Lymphoma: Efficacy and Toxicity of Intensive ЕАСОРР-14 Program (NN Blokhin National Medical Cancer Research Center Data)

Демина¹,

Леонтьева²,

Tumyan³

et al. 2017

Клиническая онкогематология

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Aim. To assess the efficacy and toxicity of intensive 6 courses EACOPP-14 treatment with or without radiotherapy (RT) for advanced stages of Hodgkin's lymphoma (HL). Materials & Methods. From November 2009 to February 2015, 95 patients with advanced stages of HL (IIX-IIE, III-IV) aged between 17 and 50 years (median 29 years) were selected for the participation in the protocol ЛХМосква1-3. The study population consisted of 46.3 % men and 53.7 % women. The results of the treatment were assessed in 91 patients who have received more than 2 courses of EACOPP-14. The follow up period was at least 3 months after the receiving the therapy. Consolidation RT with a total dose of 30 Gy for residual tumor lesions and/or initially large tumors was performed after the chemotherapy. Results. Complete remission was achieved in 82 (90.1 %) patients, partial remission in 2 (2.2 %), and the progression was observed in 7 (7.7 %) patients. The overall 4-year survival rate was 90.8 %, the progression-free survival was 88.2 %. The toxicity of the ЕАСОРР-14 program was slightly lower than that of 8 courses of ВЕАСОРРesc, and was comparable to the toxicity of other modifications of intensified ВЕАСОРР scheme. Hematological toxicity grade 3 and 4 was most commonly observed: leukopenia was observed after 64.9 % of courses, anemia - after 24 % of courses, thrombocytopenia - after 3.8 % of courses. The rate of infections did not singificantly differ and accounted for 24 %. The most frequent non-infectious complications were mucositis (21.1 %) and polyneuropathy (11.7 %). Complications resulted in the change of treatment in only 3 (3.01 %) of patients. The exclusion of bleomycine from the ЕАСОРР-14 program reduced the frequency of RT complications. Grade 3 pulmonitis developed in 4.5 % of cases, while radiation-induce pulmonary fibrosis verified by CT developed in 15.2 % of cases. The ЕАСОРР-14 6 courses program showed its high efficacy both with and without RT, high tolerance and the possibility of full administration for the majority of patients with the various stages of HL. Conclusion. Current research showed the efficacy of treatment without RT for patients with advanced stages of HL with negative PET results and small (< 2.5 cm) residual tumors after intensive ЕАСОРР-14 program. This approach allowed to avoid a number of late treatment complications.

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Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials

Cited by 100 publications

References 15 publications

Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma

Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma

The GHSG Approach to Treating Hodgkin’s Lymphoma

First-Line Therapy for Patients with Advanced Hodgkin’s Lymphoma: Efficacy and Toxicity of Intensive ЕАСОРР-14 Program (NN Blokhin National Medical Cancer Research Center Data)

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