KROPFF, Martin, Honorata Giongco BAYLON, Jens HILLENGASS, Tadeusz ROBAK, Roman HÁJEK, Peter LIEBISCH, Stefan GORANOV, Cyrille HULIN, Joan BLADE, Tommaso CARAVITA, Herve AVET-LOISEAU, Thomas M MOEHLER, Claire PATTOU, Lela LUCY, Elisabeth KUEENBURG, Axel GLASMACHER, Robert ZERBIB a Thierry FACON. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. Haematologica-the Hematology Journal. PAVIA: FERRATA STORTI FOUNDATION, 2012, roč. 97, č. 5, s. 784-791. ISSN 0390-6078. doi:10.3324/haematol.2011.044271.
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Základní údaje
Originální název Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial
Autoři KROPFF, Martin (276 Německo, garant), Honorata Giongco BAYLON (276 Německo), Jens HILLENGASS (276 Německo), Tadeusz ROBAK (616 Polsko), Roman HÁJEK (203 Česká republika, domácí), Peter LIEBISCH (276 Německo), Stefan GORANOV (276 Německo), Cyrille HULIN (276 Německo), Joan BLADE (276 Německo), Tommaso CARAVITA (276 Německo), Herve AVET-LOISEAU (276 Německo), Thomas M MOEHLER (276 Německo), Claire PATTOU (276 Německo), Lela LUCY (276 Německo), Elisabeth KUEENBURG (276 Německo), Axel GLASMACHER (276 Německo), Robert ZERBIB (276 Německo) a Thierry FACON (276 Německo).
Vydání Haematologica-the Hematology Journal, PAVIA, FERRATA STORTI FOUNDATION, 2012, 0390-6078.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30200 3.2 Clinical medicine
Stát vydavatele Itálie
Utajení není předmětem státního či obchodního tajemství
Impakt faktor Impact factor: 5.935
Kód RIV RIV/00216224:14110/12:00061480
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.3324/haematol.2011.044271
UT WoS 000304669000027
Klíčová slova anglicky thalidomide; dexamethasone; multiple myeloma; prior therapy; time to progression
Příznaky Mezinárodní význam
Změnil Změnil: Mgr. Michal Petr, učo 65024. Změněno: 25. 10. 2012 14:51.
Anotace
Background Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma. Design and Methods We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression. Results In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide. Conclusions Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. (Clinical trial registration number: NCT00452569)
VytisknoutZobrazeno: 28. 10. 2021 01:38