The gist: The drug Xalkori (aka crizotinib) has shown promise for treating people with a certain type of non-small cell lung cancer (NSCLC) who have not yet taken any other treatment. A clinical trial tested Xalkori in untreated NSCLC patients whose tumors had mutations of the ALK gene (“ALK-positive”). People who took Xalkori in the trial had almost 4 more months before their cancer worsened than people who took only chemotherapy.
“Pfizer’s targeted cancer therapy Xalkori (crizotinib) significantly extended progression-free survival in previously-untreated patients with a particular form of non-small cell lung cancer taking part in a late-stage trial compared to chemotherapy alone.
“Data from the Phase III PROFILE 1014 study, published in The New England Journal of Medicine, showed that patients with ALK-positive advanced NSCLC given Pfizer’s kinase inhibitor had a median PFS of 10.9 months compared to 7 months for those in the chemotherapy arm. Also, the objective response rate was much higher at 74% versus 45%, the firm noted.
“On the safety side, no unexpected issues arose in the trial, with the most commonly reported adverse events observed in the Xalkori being vision disorder (71%), diarrohea (61%), nausea (56%) and oedema (49%), and with chemotherapy, nausea (59%), fatigue (38%), vomiting (36%) and decreased appetite (34%).
“ALK gene rearrangements are present in about 5% of NSCLC cancers typically occurring in younger patients who don’t smoke. By identifying and enrolling only those patients whose advanced NSCLC tumours are ALK-positive, “this trial was able to demonstrate the superiority of Xalkori over an intravenous platinum-based chemotherapy regimen that has been a standard first-line treatment for more than a decade,” said Mace Rothenberg, chief medical officer for Pfizer Oncology.”
“Some patients with metastatic renal cell carcinoma (mRCC) who are switched from a traditional sunitinib treatment schedule to an alternative schedule fare better on survival measures and suffer fewer adverse events, a Japanese study has found.
“The switch from traditional to alternative schedules was recently found to be effective. But, ‘Japanese patients with mRCC experience substantially different [adverse events] than do patients in many other nations, presumably because of underlying genetic differences’, the authors write.
“They retrospectively reviewed the medical records of 54 patients with mRCC who received sunitinib treatment as first-line therapy between May 2006 and June 2012.”
“In a UK phase II study reported in the Journal of Clinical Oncology, Hillmen et al assessed the safety and activity of adding rituximab (Rituxan) to chlorambucil (Leukeran) in first-line treatment of chronic lymphocytic leukemia (CLL). Such a regimen may be an alternative to fludarabine-based treatment or chlorambucil monotherapy in elderly patients and those with comorbidities.
“In the study, 100 patients in 12 UK centers received first-line rituximab (375 mg/m2 on day 1 of cycle 1 and 500 mg/m2 thereafter) plus chlorambucil (10 mg/m2 on days 1–7) for six 28-day cycles. Patients responding but not achieving complete response could receive an additional six cycles of chlorambucil alone.
“Patients had a median age of 70 years (range, 43–86 years) and a median of seven comorbidities, 66% were male, 56% had Binet stage C disease, 36% had IgVH mutation, and 13q deletion, 12q trisomy, 11q deletion, and 17p deletion were present in 43%, 16%, 13%, and 3%, respectively.”
Editor’s note: A new clinical trial with volunteer patients tested a treatment that combines the drug chlorambucil (Leukeran) with the drug rituximab (Rituxan). The treatment was found to be safe, and may be more effective than treatment with chlorambucil alone. This combination treatment might be a good option for people with chronic lymphocytic leukemia (CLL) who might not be able to take fludarabine-based treatment, especially elderly patients and patients with comorbidities (two or more diseases).
“People with advanced skin cancer should be able to receive ipilimumab as a first treatment, the National Institute for Health and Care Excellence (NICE) proposes.
“In final draft guidance, NICE recommends that the drug ipilimumab (also called Yervoy and manufactured by Bristol-Myers Squibb Pharmaceuticals Limited) is made available on the NHS as a first-line treatment for patients with advanced malignant melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body).
“Sir Andrew Dillon, NICE chief executive, said: ‘We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first line treatment too.’ “
Editor’s note: The UK’s public healthcare system is required to provide funding for treatments recommended by NICE. To learn more about targeted melanoma drugs like ipilimumab, read The Basics.
“Adding bevacizumab (Avastin) to first-line targeted therapy delayed progression in a subgroup of non-small cell lung cancer (NSCLC), an open-label trial showed.
“Progression-free survival was 46% better with bevacizumab plus erlotinib (Tarceva), at 16.0 months compared with 9.7 on erlotinib alone in an EGFR mutation-positive population (P=0.0015), Terufumi Kato, MD, of Kanagawa Cardiovascular and Respiratory Center in Yokohama, Japan, and colleagues found.”
Editor’s note: A combination of two targeted therapy drugs has shown promise for treating some patients with non-small cell lung cancer (NSCLC). The two drugs are called bevacizumab (brand name Avastin) and erlotinib (brand name Tarceva). The research described in this story found that the combination works better for patients whose tumors have mutations in the EGFR gene (as detected by molecular testing) than erlotinib alone.
“A large phase III study investigating necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin as first-line treatment for advanced squamous non–small cell lung cancer show a statistically significant improvement in overall survival of patients with stage IV disease.
“Patients receiving necitumumab plus chemotherapy had a median survival of 11.5 months compared to 9.9 months for patients treated with chemotherapy alone.
“Progression-free survival and disease control rate were also significantly improved.”
Editor’s note: This story is about a clinical trial that is testing the effectiveness of a new treatment for lung cancer patients. So far, the trial has found that the treatment is promising for people with stage IV squamous non-small cell lung cancer (NSCLC). To learn more about clinical trials, and the risks and advantages for patients who participate in them, click here.
“The addition of palbociclib to letrozole during first-line treatment significantly extended PFS in post-menopausal patients with ER-positive, HER-2–negative advanced breast cancer, according to final results of a randomized, open-label, phase 2 trial presented at the American Association for Cancer Research annual meeting.
“Palbociclib (PD-0332991, Pfizer), an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, prevents DNA synthesis by blocking cell cycle progression. Results of preclinical studies showed HR-positive breast cancer cells are dependent on CDK-4/6 for growth, and a phase 1 study showed the combination of palbociclib and the antiestrogen drug letrozole appeared to be a safe, effective combination.”
Editor’s note: “PFS” stands for “progression-free survival.” It refers to a period of time in which a cancer patient does not experience worsening of his/her disease. In the clinical trial described here, a combination of two drugs —palbociclib and letrozole—extended PFS for some people with ER-positive, HER-2-negative advanced breast cancer.
“The German Institute for Quality and Efficiency in Health Care (IQWiG) already assessed the added benefit of ipilimumab in advanced melanoma in 2012. A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pretreated patients.”
Editor’s Note: This story is a little confusing, so here is a summary to clarify: It was already known that ipilimumab can be beneficial for people who have received previous treatment for melanoma. A new study aimed to find out if ipilimumab also improves survival for patients who have not received prior treatment. However, for a variety of reasons, the study did not show that ipilimumab performs any better than dacarbazine in patients who have not received prior treatment.
“Surgery offers better survival rates for most men with localised prostate cancer than radiotherapy, according to one of the largest studies of its type.
“The study, led by an Oxford University researcher, found that surgery as the first-line treatment offered greatest benefits for younger men in good general health.
“The international research team from the UK, Sweden and the Netherlands compared data on what happened to more than 34,000 Swedish men over a 15-year period after they had been treated for prostate cancer.
“It is hoped the findings, published online today in the British Medical Journal, could help inform treatment choice.”