Randomized Phase III Study of Pegylated Liposomal Doxorubicin Plus Bortezomib Compared With Bortezomib Alone in Relapsed or Refractory Multiple Myeloma: Combination Therapy Improves Time to Progression
| العنوان: | Randomized Phase III Study of Pegylated Liposomal Doxorubicin Plus Bortezomib Compared With Bortezomib Alone in Relapsed or Refractory Multiple Myeloma: Combination Therapy Improves Time to Progression |
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| المؤلفون: | Sen H. Zhuang, Liang Xiu, Ivan Spicka, Jean Luc Harousseau, Tadeusz Robak, Pieter Sonneveld, Joan Bladé, Wayne Rackoff, Trilok V. Parekh, Andrew Spencer, Arnon Nagler, Alexander Suvorov, Jesús F. San Miguel, Zhilong Yuan, Robert Z. Orlowski, Heather J. Sutherland, Anna Dmoszynska, Roman Hájek, Noemi Horvath |
| المساهمون: | Hematology |
| المصدر: | Journal of Clinical Oncology, 25, 3892-3901. American Society of Clinical Oncology |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2007. |
| سنة النشر: | 2007 |
| مصطلحات موضوعية: | Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, Randomization, Combination therapy, Disease-Free Survival, Polyethylene Glycols, Bortezomib, hemic and lymphatic diseases, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Doxorubicin, Survival rate, Multiple myeloma, Aged, Aged, 80 and over, business.industry, Incidence, Hazard ratio, Middle Aged, medicine.disease, Boronic Acids, Hematologic Diseases, Surgery, Regimen, Cardiovascular Diseases, Drug Resistance, Neoplasm, Pyrazines, Disease Progression, Female, Neoplasm Recurrence, Local, Multiple Myeloma, business, medicine.drug |
| الوصف: | Purpose This phase III international study compared the efficacy and safety of a combination of pegylated liposomal doxorubicin (PLD) plus bortezomib with bortezomib monotherapy in patients with relapsed or refractory multiple myeloma. Patients and Methods Six hundred forty-six patients were randomly assigned to receive either intravenous bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of an every 21-days cycle, or the same bortezomib regimen with PLD 30 mg/m2 on day 4. Results Median time to progression was increased from 6.5 months for bortezomib to 9.3 months with the PLD + bortezomib combination (P = .000004; hazard ratio, 1.82 [monotherapy v combination therapy]; 95% CI, 1.41 to 2.35). The 15-month survival rate for PLD + bortezomib was 76% compared with 65% for bortezomib alone (P = .03). The complete plus partial response rate was 41% for bortezomib and 44% for PLD + bortezomib, a difference that was not statistically significant. Median duration of response was increased from 7.0 to 10.2 months (P = .0008) with PLD + bortezomib. Grade 3/4 adverse events were more frequent in the combination group (80% v 64%), with safety profiles consistent with the known toxicities of the two agents. An increased incidence in the combination group was seen of grade 3/4 neutropenia, thrombocytopenia, asthenia, fatigue, diarrhea, and hand-foot syndrome. Conclusion PLD with bortezomib is superior to bortezomib monotherapy for the treatment of patients with relapsed or refractory multiple myeloma. The combination therapy is associated with a higher incidence of grade 3/4 myelosuppression, constitutional symptoms, and GI and dermatologic toxicities. |
| تدمد: | 1527-7755 0732-183X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4064f6874c5cbadfcd04e516972fe3d8Test https://doi.org/10.1200/jco.2006.10.5460Test |
| حقوق: | RESTRICTED |
| رقم الانضمام: | edsair.doi.dedup.....4064f6874c5cbadfcd04e516972fe3d8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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