Prostate Cancer: Poor Responders Benefit from Taxane Switch

Excerpt:

“Men with advanced prostate cancer who respond poorly to one taxane-based chemotherapy regimen may benefit from switching to another, a small randomized trial reported.

“Nearly half of the men who did not achieve a ≥30% decline in prostate-specific antigen (PSA) level while receiving either docetaxel or cabazitaxel achieved a ≥50% decline when they switched to the other drug, said Emmanuel Antonarakis, MBBCh, of Johns Hopkins University in Baltimore, and colleagues.”

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Scalp-Cooling Device Cuts Hair Loss in Breast Cancer Patients Undergoing Chemotherapy

Excerpt:

“While nothing easy or simple comes from a cancer diagnosis, one of the most traumatic experiences for breast cancer patients, particularly for women, is hair loss. Dr. Julie Nangia, assistant professor in the Lester and Sue Smith Breast Center within the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, sees this all too frequently when treating her patients.

” ‘Hair loss takes a tremendous toll on the patient’s body image, and they no longer have the anonymity of hiding the disease; everyone can see that they’re sick,’ said Nangia. ‘Patients and physicians have been hoping and searching for methods or therapies to prevent or reduce hair loss due to chemotherapy, but the options have been very limited due to the complexity of both the disease and the treatment.’

“Nangia may have found the answer in research presented at the 2016 San Antonio Breast Cancer Symposium, which details the results of a study using a scalp cooling cap to reduce hair loss in breast cancer patients undergoing taxane or anthracycline chemotherapy.”

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T-DM1 Improved Overall Survival for Heavily Pretreated Patients With HER2-positive Breast Cancer

“Among patients with HER2-positive, metastatic breast cancer that had progressed despite treatment with two or more forms of HER2-targeted therapy (trastuzumab [Herceptin] and lapatinib [Tykerb]), median overall survival was increased for those treated with trastuzumab emtansine (T-DM1 [Kadcyla]) compared with those who received treatment of physician’s choice, according to results from the phase III TH3RESA clinical trial presented at the 2015 San Antonio Breast Cancer Symposium, held Dec. 8–12.

“The HER2-targeted antibody-drug conjugate T-DM1 was approved by the U.S. Food and Drug Administration in February 2013 for treating patients with HER2-positive, metastatic breast cancer that had progressed after treatment with trastuzumab and a taxane.”


Tykerb Still Falls Short in HER2-Positive Breast Ca

“In HER2-positive breast cancer, lapatinib (Tykerb) combined with a taxane was linked to shorter progression-free survival (PFS) and more toxicity compared with trastuzumab (Herceptin) plus a taxane, according to results from an international trial.

“In the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) MA.31 study, the median intention-to-treat (ITT) PFS was 9.0 months with lapatinib versus 11.3 months with trastuzumab when paired with a taxane, according to Karen A. Gelmon, MD, of the British Columbia Cancer Agency in Vancouver, and colleagues.

“In addition, lapatinib plus a taxane was associated with more toxicity in patients with centrally confirmed HER2-positive tumors, and overall survival (OS) was worse in the confirmed HER2-positive group treated with lapatinib (ITT hazard ratio 1.28, 95% CI 0.95-1.72, P=0.11), they wrote in the Journal of Clinical Oncology.

” ‘Our results support the use of trastuzumab over lapatinib in the HER2 treatment-naive first-line metastatic setting,’ Gelmon’s group stated. ‘The NCIC CTG MA.31 trial was the first head-to-head comparison to our knowledge of trastuzumab and lapatinib in locally determined metastatic HER2-positive breast cancer, with separate analysis for centrally determined HER2 disease.’ “


AR-V7 Biomarker Could Guide Treatment in mCRPC Patients

“In men with metastatic castration-resistant prostate cancer (mCRPC), the presence of androgen receptor V7 (AR-V7) in circulating tumor cells did not significantly affect response to treatment with taxane therapy, according to the results of a small prospective study (Abstract 138) presented at a press conference held in advance of the 2015 ASCO Genitourinary Cancers Symposium.

“In fact, researchers led by Emmanuel Antonarakis, MD, assistant professor of oncology and urology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, found that men who had AR-V7 detected in circulating tumor cells (AR-V7–positive) may retain their sensitivity to taxane-based treatment.

“An earlier study by Antonarakis and colleagues found that AR-V7–positive mCRPC patients treated with either enzalutamide or abiraterone fared worse than AR-V7–negative patients.

“AR-V7 is a truncated form of the androgen receptor that is detected in about one-third of patients with CRPC. AR-V7 lacks the ligand-binding domain of the androgen receptor, the target of enzalutamide and abiraterone.”


TDM-1 Trial Disappoints in HER2-Positive Breast Cancer

The gist: A clinical trial that tested a new drug called TDM-1 (Kadcyla) found disappointing results for patients with metastatic, HER2-positive breast cancer. The trial found that treatment with T-DM1 plus the drug pertuzumab is no better than treatment with trastuzumab plus chemotherapy. For more on TDM-1, see this recent news about its potential benefits for patients whose cancer has spread to the central nervous system (CNS).

“Results of the anticipated phase III MARIANNE trial found that HER2-positive metastatic breast cancer patients treated with trastuzumab emtansine (T-DM1) plus pertuzumab had similar progression-free survival (PFS) compared with those treated with trastuzumab plus a taxane-based chemotherapy.

“Though the trial met its noninferiority endpoint, showing a similar PFS in the first-line setting between the two combination therapies along with T-DM1 alone, it failed to demonstrate that T-DM1 performs better than trastuzumab plus chemotherapy.

“The study has been anticipated by clinicians as two of the treatment arms do not include a taxane, which often causes patients to lose their hair, among other toxicities. The full results of the study will be presented at a future medical meeting…

“ ‘In my opinion, given the substantial survival associated with [docetaxel plus trastuzumab and pertuzumab of over 56 months], it remains the current first-line standard regimen especially for those patients who have never been exposed to trastuzumab,’ said Hurvitz.”


Neratinib Plus Capecitabine Shows Activity in HER2-Positive Metastatic Breast Cancer

The gist: A recent clinical trial tested a new breast cancer treatment in volunteer patients. The treatment combines a new drug called neratinib with the chemotherapy drug capecitabine. The trial found promising results for patients who had HER2-positive metastatic breast cancer and who had already been treated with trastuzumab (Herceptin) and taxanes. Some of the patients had also had prior treatment with the drug lapatinib (Tykerb). Patients interested in this treatment can now enroll in a new phase III clinical trial.

“Neratinib is an irreversible pan-tyrosine kinase inhibitor with activity against HER1, HER2, and HER4. In a phase I/II trial reported in the Journal of Clinical Oncology, Saura et al found that the combination of neratinib and capecitabine exhibited high activity in patients with trastuzumab (Herceptin)- and taxane-pretreated HER2-positive metastatic breast cancer, including those with prior treatment with the dual HER1/HER2 kinase inhibitor lapatinib (Tykerb)…

“In the phase I dose-escalation phase in 33 patients, the maximum tolerated dose of the combined regimen was found to be neratinib at 240 mg once a day continuously and capecitabine at 1,500 mg/m2 twice a day on days 1 and 14 every 21 days. No dose-limiting toxicity was observed at this level; dose-limiting toxicities at higher doses of neratinib or capecitabine included diarrhea, increased liver enzymes, and asthenia…

“In the phase II portion, 72 patients, including 7 with prior lapatinib treatment, received the maximum tolerated dose of the combination. The overall response rate in 65 patients with no prior lapatinib was 64% (95% confidence interval [CI] = 51%–76%), including complete response in 12%. In the 7 patients with prior lapatinib treatment, the response rate was 57% (95% CI = 18%–90%), including complete response in 1 patient (14%).

“Stable disease ≥ 24 weeks was achieved in an additional 8% and 14% of patients. Median progression-free survival was 40.3 weeks (95% CI = 30.3–66.0 weeks) and 35.9 weeks (95% CI = 18.9–60.1 weeks).”


Abiraterone Acetate/Prednisone in Metastatic Castration-Resistant Prostate Cancer: Final Analysis of Early-Access Protocol Study

The gist: In 2012, the U.S. Food and Drug Administration (FDA) approved a drug called Zytiga for the treatment of metastatic castration-resistant prostate cancer. It is prescribed along with the drug prednisone. Before the FDA’s approval, the Zytiga/prednisone combination was being tested in patients in a clinical trial. The trial was an “early-access” trial, meaning that it gave patients access to a very promising treatment that had not yet been approved. All patients involved had metastatic castration-resistant prostate cancer that had worsened after chemotherapy. Recently reported results from the trial showed no new safety concerns for the treatment.

“Abiraterone acetate (Zytiga) is approved for use in combination with prednisone in the treatment of metastatic castration-resistant prostate cancer. As reported by Sternberg et al in The Lancet Oncology, results of an open-label, early-access protocol trial initiated prior to approval indicated no new safety signals with abiraterone acetate plus prednisone given after progression on chemotherapy…

“The study, conducted in 23 countries, included 2,314 patients with metastatic castration-resistant prostate cancer progressing after taxane chemotherapy enrolled between November 2010 and September 2013. Patients received abiraterone acetate 1,000 mg/day and prednisone 5 mg twice a day in 28-day cycles until disease progression, development of sustained side effects, or approval and availability of abiraterone acetate in the country of residence…

“The investigators concluded: ‘No new safety signals or unexpected adverse events were found in this early-access protocol trial to assess abiraterone acetate for patients with metastatic castration-resistant prostate cancer who progressed after chemotherapy. Future work is needed to ascertain the most effective regimen of abiraterone acetate to optimise patients’ outcomes.’ ”