Subcutaneous, IV Trastuzumab Similarly Safe, Effective for HER-2-Positive Early Breast Cancer

The gist: Breast cancer patients being treated with the drug trastuzumab (Herceptin) receive the same benefits whether they take it intravenously (by IV) or as an injection.

“Subcutaneous trastuzumab demonstrated comparable safety and efficacy to IV trastuzumab in patients with HER-2–positive early breast cancer, according to results of an international randomized, open-label phase 3 study.

“Christian Jackisch, MD, PhD, of the Breast Cancer and Gynecology Cancer Center at Sana Klinikum Offenbach GmbH in Germany, and colleagues compared the pharmacokinetics, efficacy and safety of subcutaneous vs. IV trastuzumab (Herceptin, Genentech). The study included 596 women with HER-2–positive, operable, locally advanced or inflammatory breast cancer in the neoadjuvant/adjuvant setting.

“All women underwent treatment with eight cycles of neoadjuvant chemotherapy administered concurrently with trastuzumab. Trastuzumab was administered either via 3-weekly fixed doses of 600 mg or via the standard weight-based method.

“Patients continued treatment with trastuzumab for 1 year after surgery.”


Updated: New Melanoma Drug Shows Promise In Trial, But Questions About Effectiveness Remain

The gist: Earlier this month we posted about promising results from a clinical trial testing a new treatment called PV-10. Now, an oncologist who was not involved in the research has told a Forbes reporter that the results may not be as promising as they sound.

“A new cancer drug benefited 51% of stage III and IV melanoma patients during a phase II trial, achieving complete response (total cancer disappearance) in 26% during the treatment period. That was all in just 16 weeks of treatment, and would seem to suggest this drug, being developed by a small company ignored by Wall Street, has potential for treating certain cancers in the future.

“But an independent oncologist not associated with the trial says that the results may not be so impressive after all, based on the data from the published study.

John Glaspy, an oncology professor at UCLA, says that ‘it’s not clear’ whether the result are important. If they are talking about lesions that were not directly injected with the drug, the results would be meaningful. ‘If they are talking about the injected lesion, not so much,’ Glaspy says.

“When asked about it, he repeated: ‘Like I said, these SQ melanomas are an indolent disease, and it is not a big deal if you inject them and they regress.  I don’t think you have any evidence that anybody is cured.’ “


PV-10 Produced Complete Response in 50% of Advanced Melanoma Patients

“Half of patients with locally advanced cutaneous melanoma who had all their lesions injected with the investigational agent PV-10 achieved a complete response in a phase 2 study, according to a presentation at the 50th American Society of Clinical Oncology meeting, held in Chicago, IL, May 30th to June 2nd.”

Editor’s note: PV-10 is a new drug that can be injected directly into a cutaneous melanoma tumor. In a recent clinical trial testing the drug on volunteers, half of all patients who had all of their tumors injected experienced complete disappearance of their tumors.