BioOncology Watch

Timely Information for Practicing Physicians

 

NOVEMBER 1999

BREAST CANCER
Recombinant human anti-HER2 monoclonal antibody (rhuMAb HER2). Melody Cobleigh and colleagues conducted a multicenter trial in 222 women with HER2-overexpressing metastatic breast cancer in which patients were treated with single agent rhuMAb HER2 (Herceptin; Genentech, Inc.) after the cancer had failed to respond to 1 or 2 chemotherapy regimens. The intent-to-treat analysis revealed a 15% response rate (8 CRs, 26 PRs), a median time to disease progression of 3.1 months (0 to > 28 months), and a median survival time of 13 months (0.5 to > 30 months). For responders, the median duration of response was 9.1 months (1.6 to > 2.6 months). The most clinically important adverse event was cardiac dysfunction (4.7% of patients) and the most common adverse events were infusion-related fever/chills (40% of patients). These results show that rhuMAb HER2 is well tolerated and active as a single agent in patients with HER2-overexpressing progressive metastatic breast cancer. (Cobleigh MA, et al. J Clin Oncol 1999; 17: 2639-2648)

OVARIAN CANCER
Photoimmunotherapy (PIT) and cisplatin. PIT consists of the antibody-targeted delivery of a photosensitizer that is activated to a cytotoxic state by visible light and, when applied intraperitoneally, represents a potentially new therapeutic option for advanced ovarian cancer patients. Linda Duska et al. performed a preclinical study comparing the cytotoxic effects of the combination of PIT (utilizing a monoclonal antibody directed against CA 125) and cisplatin to cisplatin treatment alone in several human primary and established ovarian cancer cell lines. They observed cytotoxicity to be an average of 6.9 x greater with the combination compared to cisplatin therapy alone (P=0.023). In addition, the combination resulted in a higher increase of cytotoxicity for cisplatin-resistant cells than for cisplatin-sensitive cells (P=0.042). These data indicate that PIT may augment cisplatin therapy and possibly reverse cisplatin-resistance in human ovarian cancer cells. (Duska LR, et al. J Natl Cancer Inst 1999; 91: 1557-1563)

HEMATOLOGIC MALIGNANCIES
Interferon (IFN) and multiple myeloma. Martin Oken and colleagues report the results of an ECOG study in which previously untreated patients with active multiple myeloma (628 evaluable patients) were randomized to VBMCP chemotherapy alone, VBMCP + rIFNa2 (Schering-Plough) or VBMCP + high dose cyclophosphamide (only in patients < 70 years old). While subanalyses indicated that IFN therapy may add benefit (greater CR rate and longer response duration) to elderly patients and those with IgA myeloma, there were no differences between the 3 regimens in rates of response or survival. The results of this large trial show that the addition of IFN to VBMCP chemotherapy does not affect survival rates or overall response rates in previously untreated patients with multiple myeloma. (Oken MM, et al. Cancer 1999; 86: 957-968)

Rituximab associated cytokine release syndrome. U. Winkler and coworkers describe a cytokine-release syndrome that developed during the initial rituximab (IDEC Pharmaceuticals) infusion in 6 of 11 patients (10 B-CLL and 1 leukemic variant of mantle cell lymphoma) who presented with high peripheral blood malignant lymphocyte counts (> 50 x 109/L). In all six patients, lymphocyte counts decreased rapidly and elevated serum TNF-a and IL-6 levels were found. The syndrome is manifested by severe symptoms (fever, chills, nausea, vomiting, hypotension, dyspnea), thrombocytopenia, prolongation of the prothrombin time, and large increases of serum LDH and liver enzyme levels. These findings indicate that, in patients with high numbers of circulating malignant lymphocytes, alternative methods to lower the tumor burden (e.g, hydroxyurea or a fractionated rituximab schedule) are needed prior to the initiation of standard rituximab treatment. (Winkler U, et al. Blood 1999; 94: 2217-2224)

Interferon (IFN) effects in chronic myeloid leukemia (CML). Fabrizio Pane et al. measured levels of hybrid BCR/ABL mRNA in bone marrow mononuclear cells (MNCs) by reverse transcriptase-PCR from 20 patients with Philadelphia positive (Ph+) CML before and after therapy with IFN-a or hydroxyurea (used in IFN-a resistant CML). At the time of hematologic remission, the mean levels of BCR/ABL transcripts in marrow MNCs were reduced in those with IFN sensitive disease (P<0.001) but not in those with IFN resistant disease. Similar results were seen in cell culture experiments. These results suggest that downmodulation of BCR/ABL gene expression may be a mechanism of action of IFN-a in CML. (Pane F, et al. Blood 1999; 94: 2200-2207)

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