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干扰素与干扰素联合泼尼松用于多发性骨髓瘤缓解期维持治疗的对比:西南肿瘤协作组研究

Interferon versus interferon plus prednisone remission maintenance therapy for multiple myeloma: a Southwest Oncology Group Study.

作者信息

Salmon S E, Crowley J J, Balcerzak S P, Roach R W, Taylor S A, Rivkin S E, Samlowski W

机构信息

University of Arizona Cancer Center, Tucson, USA.

出版信息

J Clin Oncol. 1998 Mar;16(3):890-6. doi: 10.1200/JCO.1998.16.3.890.

Abstract

PURPOSE

We evaluated the vincristine, doxorubicin, and dexamethasone (VAD) regimen alone or with chemosensitizers for remission induction and interferon (IFN) versus IFN plus prednisone (IFN/P) for remission maintenance in previously untreated multiple myeloma.

PATIENTS AND METHODS

Two hundred thirty-three patients were registered for remission-induction therapy with VAD or VAD plus the chemosensitizers verapamil and quinine. Patients who achieved remission were randomized to maintenance therapy with IFNalpha 3 MU in the evening three times weekly or IFN plus 50 mg of prednisone (IFN/P) on the morning after IFN until relapse.

RESULTS

Two hundred twenty-nine patients were eligible for induction. Fatal toxicities in nine patients who received VAD plus verapamil and quinine led to closure of this arm after 47 registrations. Subsequently, all patients received VAD induction. Despite the high early mortality rate on VAD plus sensitizers, overall survival by induction arm did not differ for median or 5-year survival with approximately 40% of patients surviving 5 years. Eighty-nine eligible patients who achieved remission were randomized to maintenance. Patients who received IFN/P had improved progression-free survival (median, 19 v9 months for IFN; P = .008). After 48 months, progression-free survival on IFN/P was at the thirtieth percentile, whereas it was below the tenth percentile on IFN alone. Median survival from start of maintenance was long on both arms (57 months for IFN/P v 46 months for IFN; P = .36).

CONCLUSION

IFN/Pwas more effective than IFN alone. Improved relapse-free survival may be attributable to IFN/P or to the use of prednisone for maintenance. This latter alternative is currently being studied.

摘要

目的

我们评估了长春新碱、阿霉素和地塞米松(VAD)方案单独使用或联合化学增敏剂用于初治多发性骨髓瘤诱导缓解的疗效,以及干扰素(IFN)与干扰素加泼尼松(IFN/P)用于维持缓解的疗效。

患者与方法

233例患者登记接受VAD或VAD联合化学增敏剂维拉帕米和奎宁进行诱导缓解治疗。达到缓解的患者被随机分为维持治疗组,一组为每周三次晚上皮下注射300万单位α干扰素,另一组为IFN加50mg泼尼松(IFN/P),在注射IFN后的早晨给药,直至疾病复发。

结果

229例患者符合诱导治疗条件。9例接受VAD联合维拉帕米和奎宁治疗的患者出现致命毒性反应,导致该组在47例登记患者后停止入组。随后,所有患者均接受VAD诱导治疗。尽管VAD加增敏剂治疗的早期死亡率较高,但各诱导治疗组的总生存期在中位生存期或5年生存率方面并无差异,约40%的患者存活5年。89例达到缓解的合格患者被随机分为维持治疗组。接受IFN/P治疗的患者无进展生存期得到改善(中位生存期,IFN组为9个月,IFN/P组为19个月;P=0.008)。48个月后,IFN/P组的无进展生存期处于第30百分位数,而单独使用IFN组则低于第10百分位数。从维持治疗开始的中位生存期在两组中均较长(IFN/P组为57个月,IFN组为46个月;P=0.36)。

结论

IFN/P比单独使用IFN更有效。无复发生存期的改善可能归因于IFN/P或使用泼尼松进行维持治疗。后一种可能性目前正在研究中。

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