Naturally Occurring Symptoms May Be Mistaken for Tamoxifen Side-Effects

Excerpt:

“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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FDA Expands Approval of Nausea/Vomiting Agent

“The US Food and Drug Administration has approved the first single-dose intravenous NK1 receptor antagonist, fosaprepitant dimeglumine (Emend), for the treatment of nausea and vomiting that can accompany the use of moderately and highly emetogenic chemotherapy. The drug is approved in combination with other antiemetics.

“ ‘Despite significant advances in supportive care, nausea and vomiting has remained a challenge for many cancer patients undergoing moderately emetogenic chemotherapy—and has historically required multi-day antiemetic therapy,’ said Stuart Green, vice president, clinical research, Merck Research Laboratories, in a statement. ‘Today’s approval of an expanded indication for Emend for injection means that physicians now have a new single-dose intravenous option, combined with other anti-vomiting medicines, for the prevention of delayed nausea and vomiting in these patients.’ “


ASCO Updates Guidelines for Antiemetics During Chemo

“For patients receiving chemotherapy, the use of the oral combination of netupitant (a neurokinin 1 receptor antagonist) and palonosetron (a 5-hydroxytryptamine-3 receptor antagonist) is beneficial for prevention of acute and delayed nausea and vomiting, according to a focused guideline update published online Nov. 2 in the Journal of Clinical Oncology.

“Paul J. Hesketh, M.D., from the Lahey Hospital and Medical Center in Burlington, Mass., and colleagues conducted a targeted systematic literature review to update guidelines on use of the oral combination of netupitant and palonosetron for prevention of acute and delayed nausea and vomiting among patients receiving chemotherapy.”


APF530 Could Improve Nausea Control in Cancer Patients

“A phase III study showed that APF530, a delayed release formulation of granisetron, could improve control of emesis in cancer patients receiving highly emetogenic chemotherapy (HEC). The results were presented at the 2015 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium in San Francisco (abstract 68).

“Ian D. Schnadig, MD, of Compass Oncology in Portland, Oregon, presented the study, and said that with regards to supportive care, ‘we still have a ways to go to move the ball down the field in this important domain of cancer care.’ Specifically, managing delayed-phase chemotherapy-induced nausea and vomiting (CINV) is an unmet medical need, he said.

“The MAGIC trial was a phase III, prospective, randomized, placebo-controlled, double-dummy, double-blind trial including 942 patients receiving an HEC regimen. In one arm, patients received ondansetron and a placebo injection; in the other, they received an ondansetron placebo and a APF530 injection. Both groups received fosaprepitant and dexamethasone. The most common chemotherapy regimens were doxorubicin/cyclophosphamide-based and cisplatin-based.”


FDA Approves New Drug Treatment for Nausea and Vomiting from Chemotherapy

“The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

“Nausea and vomiting are common side effects experienced by cancer patients undergoing chemotherapy. Symptoms can persist for days after the chemotherapy drugs are administered. Nausea and vomiting that occurs from 24 hours to up to 120 hours after the start of chemotherapy is referred to as delayed phase nausea and vomiting, and it can result in serious health complications. Prolonged nausea and vomiting can lead to weight loss, dehydration and malnutrition in cancer patients leading to hospitalization.”


Rolapitant Reduced Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy or Anthracycline/Cyclophosphamide

“In a phase III study reported in The Lancet Oncology, Schwartzberg et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens.

“In this double-blind trial, patients from 170 sites in 23 countries were randomly assigned between March 2012 and September 2013 to receive oral rolapitant 180 mg or placebo 1 to 2 hours before the administration of moderately emetogenic chemotherapy. All patients received oral granisetron 2 mg and oral dexamethasone 20 mg on day 1 (except for those receiving taxanes, who received dexamethasone according to the package insert) and granisetron 2 mg on days 2 and 3. Treatment was given for up to six cycles, with a minimum of 14 days…

“The investigators concluded: ‘Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well tolerated and shows superiority over active control for the prevention of chemotherapy-induced nausea and vomiting during the 5-day (0–120 h) at-risk period after administration of moderately emetogenic chemotherapy or regimens containing an anthracycline and cyclophosphamide.’ “


Data Shows Disconnect Between Healthcare Professionals and Patient Perceptions of Impact of Chemotherapy and Radiotherapy-Induced Nausea and Vomiting

“Norgine B.V. has presented new data highlighting a perceptual gap between healthcare professionals and patients in terms of the incidence and impact on patients’ daily life of chemotherapy and radiotherapy induced nausea and vomiting (CINV/RINV).

“These data were sponsored by Norgine and presented at the joint Multinational Association of Supportive Care in Cancer (MASCC) / International Society of Oral Oncology (ISOO) 2015 Annual Meeting.

“The data demonstrate that physicians and oncology nurses overestimate the incidence of CINV/RINV, but underestimate the impact of the condition on patients’ daily lives (p1

“In addition, just 38% of patients reported full compliance with physicians’/nurses’ guidelines when self-administering anti-emetic medication, compared with 60% estimated by physicians and nurses. Leading factors given for poor patient compliance included reluctance to add to a pill burden and fear that swallowing itself would induce nausea/vomiting.”


Heron Therapeutics Announces Positive Results from Phase 3 MAGIC Study of SUSTOL®

“Heron Therapeutics, Inc. HRTX, +60.00% today announced positive, top-line results from its recently completed Phase 3 MAGIC study. MAGIC evaluated the efficacy and safety of the Company’s 5-HT3 receptor antagonist product candidate SUSTOL® (granisetron injection, extended release) as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic chemotherapy (HEC) agents.

“The MAGIC study is the only Phase 3 CINV prophylaxis study in a HEC population performed to-date to use as a comparator the currently recommended, standard-of-care, three-drug regimen: a 5-HT3 receptor antagonist (in this case ondansetron), fosaprepitant and dexamethasone. The study was conducted entirely in the U.S. and enrolled over 900 patients undergoing HEC treatment for various tumor types.”


Medical Marijuana Helpful for Cancer-Linked Symptoms

“Cannabis and cannabinoid pharmaceuticals can be helpful for nausea and vomiting, pain, and weight loss associated with cancer, according to research published online Dec. 10 in CA: A Cancer Journal for Clinicians.

“John L. Kramer, M.D., from the American Cancer Society in Atlanta, reviewed evidence for medical uses of marijuana and cannabinoids.

“Kramer notes that marijuana and cannabinoids are used for nausea and vomiting, pain, and for treatment of poor appetite and weight loss. Cannabinoids may also have a role as antineoplastic agents. More high-quality studies of marijuana and cannabinoid pharmaceuticals are necessary to elucidate the various strains of marijuana and their bioactive compounds. Studies should also explore how best to administer marijuana and its bioactive components; differences are noted in pharmacokinetics between oral ingestion and inhalation and there may be variations in clinical effect for different indications. For example, inhalation may be better for treatment of nausea and vomiting. However, smoked marijuana contains carcinogens, and may cause injury to lungs. Marijuana also has acute effects on neuropsychiatric test performance.”