Summary of 15 Studies at 2009 ASCO that Could Change Practice

The theme of the 2009 ASCO annual meeting was personalized medicine. The theme was very evident in all the studies presented, and it was clear that the treatment of cancer is truly evolving. Cancers are no longer treated with a "this drug for that type of cancer" approach and instead oncologists are testing for genetic or molecular markers to determine which treatment is best for a specific patient. These 15 studies all have potential to change oncology practice now or in the future, and we have included a link to the original abstract at the Website:

  • The ToGA trial found that trastuzumab (Herceptin), a drug previously used to treat HER2-positive breast cancer, is also effective in HER2-positive gastric cancers. In patients with locally advanced or metastatic gastroesophageal or gastric adenocarcinoma, trastuzumab plus chemotherapy showed significantly higher response than chemotherapy alone and reduced the risk of death by 26%. Abstract LBA4509.
  • Data showed administering chemotherapy to treat ovarian cancer relapse immediately after a patient tests positive for elevated CA125 does not improve survival over waiting until clinical signs of relapse. In fact, it increased the likelihood that the patient would need third-line chemotherapy earlier and worsened quality of life. Gordin J. Rustin, MD, who presented the study, suggests physicians discuss early versus late treatment after relapse with patients and the possibility of not getting regular CA125 tests. Abstract 1.
  • For oncologists who have been using bevacizumab (Avastin) off-label as a treatment for early stage colon cancer, Norman Wolmark, MD, presented results of the NSABP C-08 trial demonstrating that the drug is not effective for this indication. Investigators hope to proceed with another trial that will investigate the use of bevacizumab for 2 years rather than the 1 year used in this trial. Abstract LBA4.
  • If some of your patients with breast cancer are taking selective serotonin reuptake inhibitors (SSRI) such as fluoxetine (Prozac) and paroxetine (Paxil) along with tamoxifen, they may need to switch antidepressants. These and other drugs that inhibit the CYP2D6 pathway nearly doubled the rate of breast cancer recurrence in these patients. Antidepressants have become typical off-label treatment for the hot flashes associated with tamoxifen. The FDA plans to offer a warning about concurrent use. Investigators suggested oncologists consider using Effexor, which does not appear to inhibit tamoxifen’s efficacy. Abstract CRA508.
  • In biliary tract cancer, adding gemcitabine (Gemzar) to cisplatin chemotherapy extended overall survival by approximately 3 months compared with gemcitabine monotherapy. It also reduced the risk of death by 30% and extended PFS by 2 months compared with gemcitabine alone (8.5 mo vs 6.5 mo, respectively). A similar rate of toxicities was seen in both arms of the phase III ABC-02 trial. This finding is important, because patients with biliary tract cancer have few treatment options. Abstract 4503.
  • Although not yet approved for use, investigators for the BiovaxID vaccine expect its makers, BioVest International, to petition the FDA for approval to market the drug to patients with follicular non-Hodgkin lymphoma. The vaccine uses cells from an individual patient’s tumor and uses them to stimulate an immune response. In trials, it improved disease-free survival by 47% (14 months). This is definitely a drug to follow. Abstract 2.
  • Pemetrexed (Alimta) showed strength as a maintenance therapy in patients with nonsquamous non-small cell lung cancer (NSCLC). The 441 patients in the study who received pemetrexed and best supportive care lived an average of 3 months longer than did patients in the control group. Some critics have questioned whether the fact that all the patients had stable disease at the outset of the study (following treatment with a platinum-based chemotherapy regimen) might have given an artificial boost to the results. Abstract CRA8000.
  • Investigators with the Dutch MIRROR study recommend that breast cancer patients who have micrometastases in the sentiment lymph nodes receive treatment to reduce local recurrence risk. Treatment might include axillary lymph node dissection or radiation therapy to the nodes. Risk of local recurrence was 4.5 times greater in women who did not get additional axillary lymph node treatment for micrometastases compared with those who did. Women whose micrometastases went untreated also had an increased risk of distant recurrence. The same results did not apply to women with sentinel nodes clear of cancer or with only isolated tumor cells. Abstract CRA506.
  • Treating menopausal symptoms with estrogen and progestin significantly increases the risk of death for women who develop NSCLC. The risk was greatest for women who smoke. The lead author of the study noted that the combined hormonal therapy caused an otherwise avoidable death in nearly 1 out of 100 smokers in the trial. Women who receive combined hormonal therapy should not smoke, and physicians may want to reconsider using this regimen in current smokers. Abstract CRA1500.
  • In comparison with placebo, pazopanib (an oral drug by GlaxoSmithKline), produced a 30% overall response in a phase III study in patients with advanced renal cell carcinoma. Pazopanib also reduced the risk of tumor progression or death by 54%. In December 2008, the FDA took GlaxoSmithKline’s New Drug Application for pazopanib under review. If approved, this would offer patients another option. Abstract 5021.
  • Philip Paty, MD, Memorial Sloan-Kettering Cancer Center, co-authored a study that concluded few patients with metastatic colorectal cancer benefit from surgical excision of their primary tumor. Out of 233 patients who received standard chemotherapy without surgery, 93% had no complications with the primary tumor. There were 16 who did require emergency surgery, and 14 had successful outcomes, indicating that delaying surgery was not problematic. Dr. Platy also noted that recovery from surgery can delay the start of chemotherapy, a very effective treatment for this type of cancer. He said he expects these findings to change practice. Abstract CRA4030.
  • Studies were presented on two novel drugs designed to inhibit PARP-1, an enzyme associated with tumor proliferation and spread. BSI-201 plus chemotherapy produced clinical benefit in 61% of patients with triple-negative breast cancer. Another PARP inhibitor, olaparib, was found to shrink the tumors of 40% of patients who had treatment-resistant BRCA 1/2-deficient breast disease. PARP has been referred to as the new EGFR/VEGFR. It is likely that pharmaceutical companies will look for other effective agents to target this enzyme. Abstract 3 and Abstract 5500.
  • Adults who survive childhood cancer are less likely to adhere to the recommended screenings for breast, colon, and skin cancer, yet the radiation used to treat their childhood cancers makes them 15% more likely to develop a secondary cancer than adults in the general population. In this study, survivors considered to be at greatest risk were the least likely to undergo screening. Physicians can help by more actively encouraging adult survivors to adhere to the schedule for recommended screenings. Abstract CRA6501.
  • A phase II study of the novel agent picoplatin found that, when added to docetaxel and prednisone as first-line treatment for patients with metastatic castration-resistant (does not respond to hormonal treatment) prostate cancer, PSA levels dropped to targeted levels in 78% of patients. In addition, 58% of patients had complete response, partial response, or stable disease and PFS was increased to 8.5 months. Picoplatin is not yet approved, and its maker, Poniard Pharmaceuticals, is looking for a partner to help bring the oral and intravenous versions of picoplatin to market. Abstract 5140.
  • Vandetanib (Zactima), an oral drug that targets EGFR and VEGFR, delayed tumor progression when added to docetaxel (Taxotere) as a second-line agent in advanced NSCLC (stage IIIB or IV). The phase III trial found that compared with docetaxel plus placebo, the addition of vandetanib prolonged survival an additional 3 weeks. The vandetanib group had a 21% reduction in disease progression with a trend toward improved overall survival. They also had a better rate of objective response (17% vs 10% for the placebo arm) and their symptoms took longer to deteriorate. Such patients have few, if any, treatment options, according to Professor Roy Herbst, MD, PhD, University of Texas M. D. Anderson Cancer Center, who expects to have data on overall survival later this year. Abstract CRA8003.

Watch for extended coverage of these findings and more in the July All-ASCO issue of Oncology & Biotech News. Comment below to let us know what you think was the most important news to come out of ASCO this year.