Clinical Trial Reports

By Stanton R. Mehr
Published: Tuesday, May 25, 2010
Phase III

Quality of Life with Sunitinib or Interferon Alfa for Patients with Metastatic Renal Cell Carcinoma

The use of conventional chemotherapy in the treatment of metastatic renal cell carcinoma (mRCC) is not generally considered effective. The five-year survival rate is only as high as 20%. Targeted therapies, such as sunitinib, offer significant promise in mRCC treatment. American researchers performed an interim analysis of a multicenter trial.

The initial randomized study had found that sunitinib treatment was well tolerated and patients had significantly extended progressionfree survival and a higher objective response rate than when using interferon alfa (IFN-alfa). In the present analysis, the researchers compared the quality of life of 375 individuals who were given sunitinib (a starting dose of 50 mg/day for 4 weeks followed by 2 weeks off treatment) or 375 given IFN-alfa (subcutaneous injection on 3 nonconsecutive days/wk or with 3 million units in week 1, 6 million units in week 2, and 9 million units thereafter).

Patients completed three quality-of-life (QoL) questionnaires: (1) Functional Assessment of Cancer Therapy-Kidney Symptom Index-15 item (FKSI-15), (2) the Functional Assessment of Cancer Therapy- General (FACT-G), and (3) the EuroQol Group’s EQ- 5D. For the purposes of this study, the primary QoL endpoint was the FKSI-Disease Related Symptoms (FKSI-DRS) subscale.

For each cycle a higher (more favorable) FKSI- 15 was reported in subjects in the sunitinib group compared with the IFN-alfa group. The Table shows that sunitinib was favored across all cycles, with an overall mean difference in scores of 1.98 points for FKSI-DRS and 3.27 points for FKSI-15; both are statistically significant (P <.0001). After the first treatment cycle, within-group changes over time for postbaseline scores decreased abruptly in both FKSI- 15 and FKSI-DRS. The IFN-alfa treatment group experienced a more pronounced initial decrease, which the clinicians pointed out could be the result of the more toxic nature of IFN-alfa.

In addition to providing significantly superior efficacy when compared with IFN-alfa, sunitinib also offers a better quality of life for patients with advanced mRCC, including superior kidney cancer disease– related symptoms, the researchers concluded.

Cella D, Li JZ, Cappelleri JC, et al. Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: Results from a phase III randomized trial. J Clin Oncol. 2008;26:3763-3769.

Phase II

Children’s Oncology Group Pilot Study

Inhibition of CD22 gene expression has recently been considered a promising target for certain leukemias and lymphomas. How well the humanized monoclonal antibody epratuzumab, which is directed at CD22, is tolerated in children with relapsed acute lymphoblastic leukemia (ALL) was studied by pediatricians at the New York University School of Medicine.

Patients enrolled in the study received epratuzumab 360 mg/m²/dose intravenously twice weekly for four doses, and then a combination of four weekly doses of epratuzumab and standard reinduction chemotherapy. Following the treatment period, the investigators evaluated responses morphologically and by minimal residual disease markers. They also assessed epratuzumab’s CD22 targeting efficiency, which was noted by quantifying changes in CD22 expression using flow cytometry.

This nonrandomized, noncontrolled study comprised 15 patients with CD22-positive ALL marrow relapse. Twelve of these individuals were fully assessable for toxicity. One seizure of unclear etiology (grade 4) and one asymptomatic alanine aminotransaminase level elevation (grade 3) were the two dose-limiting toxicities that arose.

Within 24 hours of receiving epratuzumab therapy, surface CD22 was revealed in only one patient. The clinicians pointed out that this is an indication that the drug effectively targeted the leukemic cells. When chemoimmunotherapy was complete, a complete remission was achieved in nine children, seven of whom did not have evidence of minimal residue disease.

The pediatricians concluded that epratuzumab treatment in children with relapsed CD22-positive ALL is feasible. The patients tolerated the reinduction regimen acceptably, they added, and CD22 was efficiently targeted. A majority of the patients had favorable early responses. They believe that epratuzumab should be the subject of larger-scale, randomized trials.,

Raetz EA, Cairo MS, Borowitz MJ, et al. Chemoimmunotherapy reinduction with epratuzumab in children with acute lymphoblastic leukemia in marrow relapse: A Children’s Oncology Group Pilot Study. J Clin Oncol. 2008;26:3756-3762.

Treatment with Gemcitabine and Topotecan for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Can women with platinum-resistant ovarian or peritoneal cancer benefit from combination therapy with a nucleoside analog and topoisomerase 1 inhibitor? Past studies have yielded limited results using gemcitabine or topotecan, respectively. Therefore, treatment with weekly topotecan and gemcitabine in women with platinum- resistant or refractory ovarian or peritoneal cancer was tested by researchers from the Puget Sound Oncology Consortium, Seattle.

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