Results of a phase 1 study for a promising new metastatic melanoma drug were recently published in the New England Journal of Medicine. This drug targets the V600E BRAF mutation, which is very common in melanomas. Only 32 patients were studied in this preliminary trial. Of those, 24 had partial responses and 2 had complete responses. An accompanying editorial called the drug "An Unlikely Poster Child for Personalized Cancer Treatment." V600E BRAF is one of several exciting new targets in cancer therapy, and experts are hopeful that more such targets are forthcoming. See more about BRAF inhibitors in this earlier post.

Final results of the phase 3 ToGA (Trastuzumab for Gastric Cancer) trial show that Herceptin (trastuzumab) in combination with chemotherapy "can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer" according to a recent report published in The Lancet. The trial included 122 centers in 24 countries and 594 patients.

Three studies, described as the largest to date, reinforce the idea that breast tumors should be during treatment, as well as before. The studies found that the receptor status of primary tumors often changed as disease progressed. The overall discordance rate was 39%, meaning that nearly one in three patients' tumor changed its receptor status over time. Since treatment of breast cancer is driven by tumor testing, many women may be getting inappropriate drug regimens. The studies looked at HER2 and hormone receptor status. An article in OncologyStat reviews the details of the studies and comments by investigators who presented them at a recent Boston meeting.

According to the OncologyStat article, one of the investigators suggested that if deemed safe, metastatic lesions should be biopsied, especially if substantial time has elapsed since the primary tumor was tested. Several of the researchers suggested the discordance could be due to how samples are handled, variable cutoffs used by different labs for defining ER positive vs. ER negative, and the natural heterogeneity of tumors.

This recent report from OncologyStat describes a study that found mitotic index, size, and location all influence whether patients with (GIST) gastrointestinal stromal tumors should receive adjuvant imatinib (Gleevec). All of the patients' tumors had been tested to determine they were KIT-positive. This was a Phase III trial that included more than 700 patients with localized primary GIST.

In this recent HemOnc Today article, oncologist Alex Adjei of the Roswell Cancer Institute discusses the advances in lung cancer treatment that have taken place over the last couple of years. Regarding the critical IPASS study released in 2009, Adjei said, "Before IPASS, all physicians were using clinical criteria to decide whether to use an EGFR TKI... The IPASS study showed that the clinical criteria, while useful, are not perfect." More physicians are now using tumor testing to determine which patients receive these types of targeted therapy. Adjei also discusses the BATTLE trial and the promising data about crizotinib that was released at the 2010 ASCO meeting. Crizotinib targets the EML4-ALK translocation, which is found in only a subset of non-small cell lung cancer patients. (Note, registration is required but free at HemOnc Today.)

In stage I and II melanoma patients, the most important prognostic factor is the presence of tumor in sentinel nodes. This European Journal of Cancer paper reports that the EORTC Melanoma Group Sentinel Node Protocol is an effective means of evaluating disease spread in these patients.

Experts have been debating whether Genentech's Avastin is useful in metastatic breast cancer. The FDA's Oncology Drugs Advisory Committee recently voted overwhelmingly against approval of Avastin in combination with several other cancer drugs. The FDA will release its decision by Sept. 17. Genentech has reported that the company will submit data from two more Phase III trials of Avastin in first-line metastatic breast cancer over the next year: One of those trials pairs Avastin with the company's breakthrough breast cancer drug, Herceptin. One expert quoted in this Oncostat report suggests that the drug is active against breast cancer, but that Genentech will need to do biomarker studies to identify subpopulations who respond. Tumor testing is already very common in breast cancer testing, but markers of response to Avastin are still being sought.