Two Treatments Yield Similar Survival Rates in Stage III NSCLC

The gist: A recent study showed similar survival rates for two different drug combinations for stage III non-small cell lung cancer (NSCLC). The study compared  EP (treatment with the drugs etoposide and cisplatin) with CP (carboplatin plus paclitaxel). Both drug combinations were given along with radiation therapy. The study showed that EP might cause worse side effects, but the researchers say that more research will be needed to determine whether either EP or CP is better for treating stage III NSCLC.

“An analysis of Veterans Health Administration patients showed that etoposide/cisplatin (EP) and carboplatin/paclitaxel (CP) yielded similar overall survival along with radiotherapy in patients with stage III non–small-cell lung cancer (NSCLC), but EP was associated with increased morbidity. Prospective studies are still needed to determine the optimal treatment in these patients.

“ ‘There is considerable concern that CP, although better tolerated than EP, may be inferior in terms of disease control,’ wrote study authors led by Rafael Santana-Davila, MD, of the University of Washington in Seattle. To better understand the differences between the regimens, researchers looked into outcomes of patients in the VA Central Cancer Registry.

“The study included a total of 1,842 patients treated with concurrent radiotherapy and either EP or CP between 2001 and 2010. EP was used in 27% of the full cohort…

“Though the similar survival and increased morbidity with EP suggest CP may be the preferred treatment, Santana-Davila said in an email that “the study is not able to provide a firm recommendation. It has many limitations, and although we tried to adjust for confounders with several techniques, it is still a retrospective study.”

“Those limitations include a lack of data on dose or duration of therapy, and there were treatment differences such as an increased rate of consolidation chemotherapy with CP patients. The reliance on coded administrative data to identify toxicities is also less reliable than methods used in clinical trials.

“ ‘The only way we could provide firm recommendations would be with a phase III randomized trial,’ Santana-Davila said. In the meantime, the authors concluded that these results may simply help guide treatment decisions in stage III NSCLC patients.”


No Survival Difference but Greater Morbidity With Etoposide/Cisplatin vs Carboplatin/Paclitaxel With Concurrent Radiotherapy for Stage III NSCLC

The gist: Recent research comparing two drug combinations for stage III non-small cell lung cancer (NSCLC) suggests that the drug combo etoposide/cisplatin does not help people live longer than carboplatin/paclitaxel does, and it also may result in more side effects. Both drug combos are taken alongside radiation treatment.

“In an analysis of Veterans Health Administration data reported in the Journal of Clinical Oncology, Santana-Davila et al found that etoposide/cisplatin resulted in no overall survival difference but greater morbidity compared with carboplatin/paclitaxel used concurrently with radiotherapy in patients with stage III non–small cell lung cancer (NSCLC).

“The analysis involved 1,842 patients treated with etoposide/cisplatin (n = 499) or carboplatin/paclitaxel (n = 1,343) between 2001 and 2010. In a Cox proportional hazard model, age (hazard ratio [HR] = 1.08, P = .0258), percentage weight loss (HR = 1.04, P < .0001), baseline anemia (HR = 1.19, P = .0064), hypoalbuminemia (HR = 1.29; 95% confidence interval [CI] = 1.14–1.46; P < .001), and treatment era (HR = 0.89 for 2005-2007 and 0.83 for 2008-2010 vs 2001-2004, P = .028) were independently associated with overall survival, whereas chemotherapy regimen (median overall survival = 17.3 months for etoposide/cisplatin vs 14.6 months for carboplatin/paclitaxel, HR = 0.97, P = .6327), stage (HR = 1.08, P = .185, for IIIB vs IIIA), and National Cancer Institute combined index score (HR = 1.17, P = .0503) were not associated with survival…

“The investigators concluded: ‘After accounting for prognostic variables, patients treated with [etoposide/cisplatin vs carboplatin/paclitaxel] had similar overall survival, but [etoposide/cisplatin] was associated with increased morbidity.’ ”


Olaparib Tablet Found Safe and Effective in Heavily Pretreated Patients With Ovarian Cancer

The gist: Patients with advanced ovarian cancer who have already had three to eight treatments might benefit from a new treatment that combines the drugs olaparib, paclitaxel, and carboplatin. That was the insight from a recent clinical trial—a research study with volunteer patients. The clinical trial found the combination treatment to be safe and effective at shrinking tumors, especially for women with BRCA mutations.

“A phase Ib clinical trial of the tablet form of olaparib, a PARP inhibitor, in combination with paclitaxel and carboplatin chemotherapy in heavily pretreated patients with advanced-stage ovarian cancer finds the drug to be safe and effective, especially in those women with BRCA gene mutations. The study by Rivkin et al was presented at the Marsha Rivkin Center for Ovarian Cancer Research–AACR 10th Biennial Ovarian Cancer Research Symposium, held September 8 to 9, in Seattle…

“The purpose of this study was to establish the maximum-tolerated dose of olaparib and to evaluate dose-limiting toxicities and response to therapy of the tablet form of olaparib plus carboplatin and paclitaxel in women with stage III or IV ovarian cancer. The researchers enrolled 14 heavily pretreated (from three to eight prior therapies) patients in the study, aged 42 to 77. All the patients were tested for BRCA2 and BRCA2 gene mutations.

“Patients received paclitaxel and carboplatin weekly for 3 out of 4 weeks, with increasing doses of olaparib. The maximum tolerated dose of olaparib was found to be 150 mg twice daily for 3 consecutive days of each week of each cycle.”


Breast Cancer Specialist Reports Advance in Treatment of Triple-Negative Breast Cancer

“Because of its rapid growth rate, many women with triple-negative breast cancer receive chemotherapy to try to shrink it before undergoing surgery. With the standard treatment, the cancer is eliminated from the breast and lymph nodes in the armpit before surgery in about one third of women. This is referred to as a pathologic complete response (pCR). In patients who achieve pCR, the cancer is much less likely to come back, spread to other parts of the body, and cause the patient’s death than if the cancer survives the chemotherapy.

“Sikov and his collaborators studied the addition of other drugs – carboplatin and/or bevacizumab – to the standard treatment regimen to see if they could increase response rates. More than 440 women from cancer centers across the country enrolled in this randomized clinical trial.

” ‘Adding either of these medications significantly increased the percentage of women who achieved a pCR with the preoperative treatment. We hope that this means fewer women will relapse and die of their cancer, though the study is not large enough to prove this conclusively. Of the two agents we studied, we are more encouraged by the results from the addition of carboplatin, since it was associated with fewer and less concerning additional side effects than bevacizumab,’ Sikov explains.”

Editor’s note: This article describes the results of a clinical trial—a research study with volunteer patients.


Nimotuzumab Plus Chemotherapy Versus Chemotherapy Alone in Advanced Non-Small-Cell Lung Cancer: A Multicenter, Randomized, Open-Label Phase II Study

“The purpose of this study was to evaluate the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin) versus chemotherapy alone in patients with stage IIIB/IV non–small–cell lung cancer. Nimotuzumab plus chemotherapy significantly improved the objective response rate as compared with chemotherapy alone. The combination was safe and well tolerated in patients with stage IIIB/IV non–small–cell lung cancer.”

Editor’s note: This article covers a new treatment that was tested in volunteer patients in a clinical trial. The treatment combines a new drug called nimotuzumab with the standard chemotherapy drugs docetaxel and carboplatin. The patients involved in the study all had stage IIIB or stage IV non-small cell lung cancer (NSCLC). Some of them received the nimotuzumab + chemo treatment while, for comparison, some received chemotherapy alone. Patients who took the nimotuzumab treatment experienced more tumor shrinkage than the patients who took chemo alone.


AbbVie Initiates Veliparib Phase III Trial in BRCA-mutated Advanced Breast Cancer Patients

“AbbVie has initiated its Phase III trial investigating the safety and efficacy of the investigational PARP inhibitor veliparib in combination with carboplatin and paclitaxel in advanced breast cancer patients.

“In the double-blind study, researchers will randomize nearly 300 patients to receive either veliparib, plus the carboplatin/paclitaxel combination, or just the chemotherapy regimen. Metastatic or locally advanced breast cancer patients enrolled in the trial will have to have tumors that are HER2 negative, but positive for BRCA1/2 mutations. AbbVie is working with Myriad Genetics to use its BRACAnalysis test to gauge BRCA mutations in study subjects.

“Researchers will assess in the study whether adding veliparib significantly increases patients’ progression-free survival compared to treatment with only chemotherapy. Other endpoints in the study are overall survival, clinical benefit rate, objective response rate, and duration of response.”

Editor’s note: Clinical trials are research studies that test new treatments on volunteer patients. In many clinical trials, some patients receive the new drug being tested, and for comparison, some patients receive “standard of care” treatment, meaning a U.S. Food and Drug Administration (FDA)-approved treatment that their oncologists would likely have considered for them. This story discusses a new clinical trial that is testing a drug called veliparib. The trial is enrolling people with advanced breast cancer who are HER2 negative and have BRCA1/2 mutations. Some of the patients will be treated with standard chemotherapy (a combination of the drugs carboplatin and paclitaxel), and some will receive veliparib PLUS standard chemotherapy. The trial is randomized, meaning patients will not get to choose which of the two treatments they receive. The goal of the clinical trial is to figure out whether adding veliparib to the chemo improves outcomes for patients.


Helix BioPharma Corp. Receives U.S. Food and Drug Administration Approval to Initiate a Clinical Trial of L-DOS47 in Combination With Pemetrexed and Carboplatin

“Helix BioPharma Corp. (frankfurt:HBP), a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”), to initiate a Phase I clinical trial with L-DOS47.

“The study is entitled “A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer”.”

Editor’s note: Clinical trials can be a way for some lung cancer patients to access certain treatments they would not otherwise be able to have. Learn more.