TOP ESMO NEWS-PART I

1. Efficacy results from the ToGA trial show the clinical benefits of adding trastuzumab to first-line standard chemotherapy in HER2-positive advanced gastric cancer The ToGA study is the first randomized, prospective, multicenter, phase III trial to study the efficacy and safety of trastuzumab in HER2-positive gastric cancer. Study results indicate that trastuzumab plus chemotherapy is superior to chemotherapy alone in HER2-positive patients. Prof. Eric Van Cutsem of the Digestive Oncology Unit, Leuven University, Belgium, presented these results during the ASCO Annual Meeting (29 May – 2 June 2009, Orlando, USA). They represent practice-changing data with indication for HER2 assessment and a benefit for trastuzumab treatment in HER2-positive gastric cancer patients. This is the first cancer localization beyond breast, where anti-HER2 therapy shows benefit. Read more…

2. Radiotherapy plus short-term androgen suppression provides inferior survival compared with radiotherapy plus long-term suppression in locally advanced prostate cancer Dr Michel Bolla of the Department of Radiation Oncology, Grenoble University Hospital, France, and colleagues from the European Organization for Research and Treatment of Cancer (EORTC) Radiation Oncology Group and Genito-Urinary Tract Cancer Group registered 1113 men, of whom 970 were randomly assigned: 483 to short-term suppression and 487 to long-term suppression. The 5-year overall mortality for short-term and long-term androgen suppression was 19.0% and 15.2%, respectively. Adverse events in both groups included fatigue, diminished sexual function, and hot flushes. Read more…

3. Three important abstracts confirmed the need to perform KRAS testing before prescribing anti-epidermal growth factor receptor (EGFR) monoclonal antibodies to patients with colorectal cancer The randomized, phase III study of panitumumab with FOLFIRI versus FOLFIRI alone showed significantly improved progression-free survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) who received panitumumab with chemotherapy as second-line treatment. Dr Marc Peeters of the Digestive Oncology Unit, University Hospital Ghent, Belgium, presented the results at the Joint ECCO 15 – 34 ESMO Congress on 20–24 September 2009 in Berlin, Germany. The results of the randomized, phase III study of panitumumab with FOLFOX4 compared with FOLFOX4 alone as first-line treatment for mCRC (PRIME trial) were reported by Dr Jean-Yves Douillard of the Medical Oncology Branch at Centre Rene Gauducheau in Nantes, France. In patients with mutated KRAS, panitumumab proved detrimental. Intermittent versus continuous oxaliplatin-based combination chemotherapy with cetuximab was tested in a randomized non-inferiority trial (MRC COIN) in patients with advanced CRC. Balanced against fewer side effects, patient survival was shorter with intermittent chemotherapy. Results were presented by lead author Dr Tim Maughan of Cardiff University, UK. Read more…

4. Combination of reduced dosage for induction therapy followed by maintenance therapy may be a novel approach in untreated patients over the age of 65 with multiple myeloma Melphalan with prednisone has been the gold standard for treating elderly multiple myeloma patients for the past 40 years, but novel combination therapies have emerged as superior options. In a study presented at the Plenary Scientific Session of the 51st Annual Meeting of the American Society of Hematology (5–8 December 2009, New Orleans, USA), 260 patients with a median age of 75 were randomized to receive a modified induction schedule of six cycles of bortezomib, melphalan, and prednisone (VMP) or bortezomib, thalidomide, and prednisone (VTP) as induction therapy, followed by maintenance therapy with bortezomib and thalidomide (VT) or bortezomib and prednisone (VP) for up to 3 years. Study results were presented by lead author Dr Maria-Victoria Mateos of the Hematology Department, Hospital Universitario de Salamanca, Spain. Read more…

5. Sunitinib significantly improves progression-free survival for patients with progressive well-differentiated pancreatic islet cell tumors Dr Eric Gregory from the Medical Oncology Service, Inter Hospitalier de Cancerologie Bichat-Beaujon in Clichy, France, presented new encouraging data at the ESMO Conference: 11th World Gastrointestinal Cancer Congress (Barcelona, 24–27 June 2009). During a 20-month period, 154 patients with progressive, well differentiated, malignant pancreatic islet cell tumors were randomized to receive best supportive care and either placebo or sunitinib. Progression-free survival in the sunitinib treated groups was 11.1 months, compared with 5.5 months for placebo. Read more…

6. RIBBON-2 is the first positive phase III study of bevacizumab in second-line metastatic breast cancer Dr Sarah Hurvitz from the University of California, Los Angeles, USA, presented on 12 December 2009 at the San Antonio Breast Cancer Symposium results from the RIBBON-2 trial – a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of HER2-negative metastatic breast cancer. For the primary efficacy analysis, progression-free survival was 7.2 months in the bevacizumab treatment arm, compared with 5.1 in the placebo arm. Overall response rate was 39.5% in the bevacizumab arm versus 29.6% in the placebo arm. Overall survival rates for the bevacizumab arm and the placebo arm (18.0 months and 16.4 months, respectively) were not significantly different, but these are still early data. Read more…

7. In 2009, the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) approved next new agents or extended indications for existing agents. The Committee: Extended the indication for rituximab to the first-line treatment of patients with chronic lymphocytic leukemia in combination with chemotherapy. Read more… Extended the indication for imatinib to the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumors (GIST). Read more… Granted a marketing authorization for gefitinib to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR). Read more… Granted a marketing authorization for everolimus to the second line treatment of advanced renal cell carcinoma in patients whose disease has progressed despite treatment with vascular endothelial growth factor (VEGF)-targeted therapy. Read more… Extended the indication for pemetrexed as a monotherapy maintenance treatment for locally advanced or metastatic NSCLC in patients whose disease has not progressed immediately following platinum-based chemotherapy. Read more… Granted a marketing authorization for vinflunine to treat carcinoma of the urothelial tract. Read more… Extended the indication, adding a new treatment option, for bevacizumab in combination therapy with docetaxel in the first-line treatment of metastatic breast cancer. Read more… Extended the indication for temsirolimus to include the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma. Read more… Recommended patupilone as an orphan medicinal product for treating primary peritoneal cancer and fallopian tube cancer. Read more… Adopted a positive opinion for adding a new treatment option for trabectedin in combination with pegylated liposomal doxorubicin for treating patients with relapsed platinum-sensitive ovarian cancer. Read more… Extended the indication for trastuzumab to include the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastro esophageal junction who have not received prior anti-cancer treatment for their metastatic disease in combination with capecitabine or 5-fluorouracil and cisplatin. Read more… Adopted a positive opinion for catumaxomab for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. Read more…