Naturally Occurring Symptoms May Be Mistaken for Tamoxifen Side-Effects


“Women taking tamoxifen to prevent breast cancer were less likely to continue taking the drug if they suffered nausea and vomiting, according to new data presented at the San Antonio Breast Cancer Symposium today (Friday).

“The researchers found that women who experienced these symptoms after starting tamoxifen as part of the Cancer Research UK funded International Breast Cancer Intervention Study (IBIS-1), were more likely to stop taking the medication.

“But this new analysis also reveals that women given a placebo who experienced the same symptoms were equally as likely to stop. This suggests that some symptoms due to other causes, were being mistaken for side effects of tamoxifen.”

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ArQule Announces Positive Top-Line Results of NIH-Sponsored Phase 2 Trial of Tivantinib in Prostate Cancer

The gist: A drug called tivantinib is showing some promise for treating patients with metastatic castration-resistant prostate cancer. Tivantinib was compared to a placebo in a clinical trial with volunteer patients. In the trial, patients who took tivantinib went for a longer time without their cancer worsening that patients who took the placebo.

“ArQule, Inc. (ARQL) today announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer. This trial ( identifier NCT01519414) was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) (‘A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of ARQ 197 (tivantinib) in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer,’ NCI Protocol # 8986). The principal investigator was J. Paul Monk, M.D. of The Ohio State University, Arthur G. James Cancer Hospital and Solove Research Institute.

“In this trial, 78 patients were randomized 2 to 1 to receive either tivantinib as a single agent or placebo. During a pre-planned analysis, it was found that the trial met its primary endpoint of improving median progression-free survival (PFS) with tivantinib alone as compared to placebo. The results were highly statistically significant. Safety data were consistent with those observed in other trials of tivantinib.

“The results of the trial are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference. As final data emerge from this trial, ArQule and its partner, Daiichi Sankyo Company, Limited, will discuss with the National Institutes of Health (NIH) the potential for additional trials in this indication.

“ ‘We are pleased that these significant findings from the NIH trial in prostate cancer add to the body of clinical evidence of the anti-cancer activity of tivantinib across multiple tumor types,’ said Paolo Pucci, chief executive officer of ArQule.”

No Survival Benefit With Pan-HER Tyrosine Kinase Inhibitor Dacomitinib vs Placebo in Pretreated Advanced NSCLC

The gist:A drug called dacomitinib does not increase survival time for people with non-small cell lung cancer (NSCLC) that is metastatic or is at an advanced stage and has already been treated. That was the conclusion of a recent clinical trial with volunteer patients.

“In the phase III NCIC CTG BR.26 Trial reported in The Lancet Oncology, Ellis et al found that treatment with the irreversible pan-HER tyrosine kinase inhibitor dacomitinib was not associated with an overall survival benefit compared with placebo in patients with pretreated advanced or metastatic non–small cell lung cancer (NSCLC)…

“In this double-blind trial, 720 patients from 75 centers in 12 countries were randomly assigned 2:1 between December 2009 and June 2013 to receive oral dacomitinib 45 mg once daily (n = 480) or placebo (n = 240) until disease progression or unacceptable toxicity. Patients had received three or fewer previous lines of chemotherapy and either gefitinib (Iressa) or erlotinib. The primary endpoint was overall survival in the intention-to-treat population. The study is completed, but follow-up is ongoing for patients on treatment.

“The dacomitinib and placebo groups were generally balanced for baseline characteristics, including age (median, 64 and 66 years, 46% and 53% ≥ 65 years), sex (51% and 50% male), Eastern Cooperative Oncology Group performance status (0 or 1 in 75% and 76%), never smoker status (36% and 35%), histology (adenocarcinoma in 75% and 70%), ethnicity (60% white in both, 29% East Asian in both, 6% and 7% other Asian), previous chemotherapy regimens (2 in 60% and 62%, ≥ 3 in 12% in both), best response to previous EGFR tyrosine kinase inhibitor (complete or partial response in 13% in both), previous pemetrexed (Alimta) for advanced disease (59% and 53%), measurable disease (94% and 95%), EGFR status (mutant in 24% and 28%, wild-type in 49% and 48%, unknown in 27% and 24%), and KRAS status (mutant in 12% and 9%, wild-type in 46% and 50%, unknown in 42% and 41%)…

“The investigators concluded: ‘Dacomitinib did not increase overall survival and cannot be recommended for treatment of patients with advanced non-small-cell lung cancer previously treated with chemotherapy and an EGFR tyrosine-kinase inhibitor.’ “

Lanreotide Improves Survival with Enteropancreatic Tumors

The gist: A clinical trial with volunteer patients tested the effectiveness of a drug called lanreotide for people with grade 1 or 2 metastatic enteropancreatic neuroendocrine tumors. The researchers found that, compared to taking a “fake” placebo drug, lanreotide increased the amount of time patients lived without their disease worsening. However, lanreotide did not improve overall survival or quality of life.

“Lanreotide significantly improves survival among patients with metastatic enteropancreatic neuroendocrine tumors (grade 1 or 2), according to a study published in the July 17 issue of the New England Journal of Medicine.

“Martyn E. Caplin, D.M., from Royal Free Hospital in London, and colleagues conducted a multinational study of patients with advanced, well-differentiated or moderately-differentiated, nonfunctioning, somatostatin receptor-positive neuroendocrine tumors (grade 1 or 2 that originated in the pancreas, midgut, or hindgut, or were of unknown origin) and documented disease-progression status. Participants were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide at a dose of 120 mg (101 patients) or placebo (103 patients) once every 28 days for 96 weeks.

“The researchers found that, compared to placebo, lanreotide was associated with significantly prolonged progression-free survival (P placebo group. In predefined subgroups, the therapeutic effect was generally consistent with that found in the overall population. Groups were similar in quality of life and overall survival. Diarrhea was the most common treatment-related adverse event (26 percent of the lanreotide group versus 9 percent of the placebo group).”

Phase III Trial Shows Improved Survival with TAS-102 in Metastatic Colorectal Cancer Refractory to Standard Therapies

“The new combination agent TAS-102 is able to improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers said.

” ‘Around 50% of patients with colorectal cancer develop metastases but eventually many of them do not respond to standard therapies,’ said Takayuki Yoshino of the National Cancer Centre Hospital East in Chiba, Japan, lead author of the phase III RECOURSE trial. ‘The RECOURSE study shows that TAS-102 improves overall survival in these patients compared to placebo. I believe that this agent will become one of the standards of care in the refractory setting of metastatic colorectal cancer in Japan and worldwide.’

“TAS-102 is a novel nucleoside anti-tumour agent consisting of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is the active component of TAS-102 and is directly incorporated into cancer DNA, leading to DNA dysfunction. However, when FTD is taken orally it is largely degraded to an inactive form. TPI prevents the degradation of FTD. This mechanism of action is different to that of fluoropyrimidine, oxaliplatin and irinotecan…

“Douillard concluded: ‘In RECOURSE, TAS-102 was tested in patients who had received all types of chemotherapy available for colorectal cancer. I would probably move this drug into an earlier line of treatment and I would also combine it with either irinotecan or oxaliplatin.’ ”

Editor’s note: This story discusses the results of a clinical trial that tested a new treatment for colorectal cancer in volunteer patients. The trial tested whether the treatment—called TAS-102—benefits people with metastatic cancer that has not responded to standard treatment. Some patients in the trial were treated with TAS-102, and for comparison, some were given a “fake” placebo treatment. The results showed that patients treated with TAS-102 survived longer than patients who took the placebo.