“A novel immune-based combination therapy for the initial treatment of chronic lymphocytic leukemia (CLL) does not appear to improve on results achieved with established regimens that include chemotherapy.
“In a phase 2 study, investigators combined rituximab (Rituxan, MabThera and Roche), the monoclonal antibody widely used for CLL, and lenalidomide (Revlimid, Celgene), an immunomodulatory agent that is not approved in these patients.
“The idea behind the pairing was to avoid chemotherapy, which is generally not well tolerated by older or infirm CLL patients and is part of all regimens containing rituximab, say the investigators, led by Danelle James, MD, from the Moores Cancer Center at the University of California, San Diego.”
Editor’s note: A potential alternative to chemotherapy for chronic lymphocytic leukemia (CLL) was tested in volunteer patients, but did not show improved results over chemo. The treatment combines the drug Rituxan with another drug called Revlimid, which is meant to boost a patient’s immune system to help fight cancer. Researchers hope to test other combinations of non-chemo drugs to see if they will prove more successful.
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“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.
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“Cisplatin, etoposide, and irinotecan outperformed topotecan as second-line chemotherapy in patients with sensitive relapsed small-cell lung cancer (SCLC) in a Japanese trial, though there was substantially increased toxicity with the regimen.
“ ‘Topotecan is the only drug approved in the United States and the European Union for relapsed SCLC,’ said Koichi Goto, MD, PhD, of the National Cancer Center Hospital East in Chiba, Japan. He presented results of the new trial at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Sensitive relapse refers to cancers that respond to initial chemotherapy and relapse more than 3 months after completion of that therapy, while refractory cancers do not respond initially or relapse within that 3 month window.”
Editor’s note: This story is about a clinical trial with volunteer patients to test a new treatment for small cell lung cancer (SCLC). The new treatment is specifically for people with SCLC who were treated with chemotherapy successfully, but whose cancer returned more than 3 months after chemo—this is known as “sensitive relapsed SCLC.” The new treatment combines three chemo drugs: cisplatin, etoposide, and irinotecan. In the clinical trial, some patients took the chemo combo and some were treated with the chemo drug topotecan, which is a standard treatment for the condition. Patients who took the new treatment lived longer, but they had more toxic side effects than the patients who took topotecan.
“The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.
The approval was based on the results of a multicenter, randomized, open-label trial comparing ofatumumab in combination with chlorambucil to single-agent chlorambucil.
Editor’s note: Once a newly developed drug has passed testing in clinical trials with volunteer patients, the U.S. Food and Drug Administration (FDA) decides whether to approve it, allowing doctors throughout the U.S. to prescribe it to patients with certain conditions. The FDA has now approved a new treatment for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based treatment is not a good option. The new treatment combines a drug called ofatumumab (brand name Arzerra) with a drug called chlorambucil (Leukeran).
“The addition of ramucirumab to docetaxel improved outcomes over placebo with docetaxel as a second-line treatment of patients with advanced non-small-cell lung cancer (NSCLC), according to results of the REVEL trial presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
“ ‘Despite advancements in genomics and identification of predictive biomarkers such as EGFR mutations or ALK rearrangement, there is still no… targeted therapy for the majority of patients with squamous and non-squamous carcinoma,’ said Maurice Pérol, MD, of the Cancer Research Center of Lyon in France. Ramucirumab specifically targets VEGFR-2 and inhibits angiogenesis, and it has been shown to improve outcomes in gastric cancer as monotherapy.”
Editor’s note: This article describes a treatment for advanced non-small cell lung cancer (NSCLC) that combines a new targeted drug called ramucirumab with the standard chemotherapy drug docetaxel. In a clinical trial to test the treatment in volunteer patients who had already received one previous treatment, it was found that ramucirumab plus docetaxel provided better patient outcomes than docetaxel plus a placebo.
“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).
“In the first phase III trial assessing the combination of an insulin-like growth factor 1 receptor (IGF-1R) inhibitor with chemotherapy as first-line treatment for advanced nonadenocarcinoma non–small cell lung cancer (NSCLC), the addition of the fully human immunoglobulin G2 monoclonal antibody figitumumab to paclitaxel/carboplatin did not improve overall survival over chemotherapy alone. The study, reported by Langer et al in Journal of Clinical Oncology, was stopped early due to futility and an increased frequency of serious adverse events, including treatment-related death, in patients receiving figitumumab.”
Editor’s note: In a clinical trial with volunteer patients, a new drug called figitumumab did not show any benefits over standard chemotherapy. The clinical trial was stopped earlier than scheduled because of serious side effects of fogitumumab, including, for some patients, death.