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Februrary 2008 Clinical Trial Reports

By Stanton R. Mehr
Published: Wednesday, Jun 23, 2010
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â–º PHASE III

What Factors Predict Prognosis in Patients With Malignant Pleural Mesothelioma?


Unlike other advanced types of cancer, little is known about patient-related symptoms or quality of life associated with malignant pleural mesothelioma (MPM), nor is there information about whether these patient-reported measures have prognostic value. Clinicians from Europe, Egypt, and Canada assessed the prognostic value of patient-related symptoms or quality-of-life information using data from a randomized, controlled phase III clinical trial of cisplatin and raltitrexed.

Patients were eligible to enter the trial if they had a histologically proven unresectable MPM that was not pretreated with chemotherapy; a World Health Organization (WHO) performance status score of no more than 2; and adequate renal, hematologic, and hepatic function. Patients were randomly assigned to receive cisplatin 80 mg/m2 intravenously on day 1, with or without preceding infusion of raltitrexed 3 mg/m2. The European Organisation for Research and Treatment of Cancer (EORTC) QLQC30/ Lung Cancer 13 tool was utilized to assess health-related quality of life.

Of the 250 original participants (80% male; median age, 58 yr; WHO performance status 0, 1, 2 in 25%, 62%, and 13% of cases, respectively) randomly assigned, 229 (91.6%) had a valid quality-of-life assessment. According to a Cox proportional hazards regression model, patient-reported pain (P < .0001), prognostic index (PI), and appetite loss (P = .01) were independent indicators of survival. These results suggest, the clinicians concluded, that pain, PI and appetite loss may be independent prognostic factors in patients with advanced MPM.


Bottomley A, Coens C, Efficace F, et al: Symptoms and patient-reported well-being: Do they predict survival in malignant pleural mesothelioma? A Prognostic factor analysis of EORTC-NCIC 08983: Randomized Phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol 2007;25:5770-5776.

Treatment for Patients With High-Risk Postoperative Breast Cancer

Patients with advanced, recurrent breast cancer have limited options to help manage tumor growth. High-dose chemotherapy (HDC) has been viewed as a possible alternative to moving to a palliative approach. Researchers from Japan have completed a randomized, controlled study to assess the efficacy of HDC as part of the treatment for high-risk postoperative breast cancer.

Patients younger than 57 years were invited to participate in this study. Each patient had stage I to IIIB breast cancer that involved 10 or more axillary lymph nodes (median, 16; range, 10–49). Ninety-seven patients (median age, 46 yr) were originally enrolled between May 1993 and March 1999, although two were later considered ineligible. A total of 72 (74%) of the subjects were premenopausal. Every patient had had a radical mastectomy.

Patients were randomized to receive one of two treatment arms; the treatment groups had similar demographic and clinical characteristics. Patients in the standard-dose treatment group (N = 48) were given six courses of cyclophosphamide, doxorubicin, and 5-fluorouracil followed by tamoxifen. The other 49 patients in the HDC treatment arm were scheduled to receive cyclophosphamide and thiotepa after six courses of cyclophosphamide, doxorubicin, and 5-fluorouracil, after which tamoxifen was administered. However, the clinicians noted, 15 of those patients (31%) did not undergo HDC. In the remaining patients, they noted that HDC was well tolerated, and there was no treatment-related mortality.

The five-year relapse-free survival was 37% for 47 eligible patients in the standard treatment arm and 52% for the 48 eligible patients in the HDC arm on an intent-to-treat basis (median follow- up, 63 mo [P = .17]). For all of the randomized patients, the five-year overall survival was 62% for the standard treatment arm and 63% for the HDC arm

(P = .78).

No advantage for the use of HDC was found, the researchers acknowledged. Nonsignificant differences in relapse-free survival and overall survival do not advocate for the use of HDC in this patient cohort.


Tokuda Y, Tajima T, Narabayashi M, et al: Phase III study to evaluate the use of high-dose chemotherapy as consolidation of treatment for highrisk postoperative breast cancer: Japan Clinical Oncology Group study, JCOG 9208. Cancer Sci 2008;99:145-151.





â–º PHASE II

Epratuzumab Plus Rituximab Equals Non-Hodgkin’s Lymphoma Response


Epratuzumab, an anti-CD22 humanized monoclonal antibody, used in combination with rituximab has produced durable complete responses in patients with recurrent or refractory non-Hodgkin’s lymphoma (NHL), according to final clinical trial results presented by John P. Leonard, MD, Weill Cornell Medical College, at the 49th annual meeting of ASH in Atlanta, Georgia.


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