Clinical Trial Reports: October 2007

By Stanton R. Mehr
Published: Wednesday, Jun 30, 2010
%u25BA PHASE III

Is Combination or Sequential Treatment for Metastatic Colorectal Cancer More Effective?


Optimal treatment of advanced colorectal cancer is still very much a dynamic question. In order to determine whether combination treatment is better than sequential administration, researchers from The Netherlands conducted a study of 820 patients with advanced colorectal cancer who received the same chemotherapeutic drugs.

All of the subjects had advanced colorectal cancer. After randomization to receive either first-line treatment with capecitabine, second- line irinotecan, and third-line capecitabine plus oxaliplatin (dubbed sequential treatment; N = 410) or first-line treatment with capecitabine plus irinotecan and second-line capecitabine plus oxaliplatin (called combination treatment; N = 410). Overall survival was the primary endpoint.

Seventeen patients were determined ineligible for study inclusion. During the trial period, 675 (84%) subjects died (336 in the sequential group, 339 in the combination group). A median overall survival of 16.3 months (95% confidence interval [CI], 14.3–18.1 mo) was noted for patients in the sequential treatment group compared with 17.4 months (95% CI, 15.2–19.2 mo) for the combination treatment group (P = .3281). The combination treatment versus sequential treatment hazard ratio was 0.92 (95% CI, 0.79–1.08; P = .3281). No significant difference was seen in the frequency of grade 3 or 4 toxicity over all lines of treatment between the two groups, except for grade 3 hand–foot syndrome (13% sequential group vs. 7% combination group; P = .004).

Overall survival was not significantly improved by using a combination treatment instead of the sequential use of cytotoxic drugs in patients with advanced colorectal cancer, acknowledged the researchers. Therefore, they added, sequential therapy is still a valid treatment option.


  Koopman M, Antonini NF, Douma J, et al: Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): A phase III randomized controlled trial. Lancet 2007;370:135-142.,





Cervical Cancer Vaccines Do Not Work Like Investigational Cancer Vaccines, Study Confirms

The FDA-approved human papillomavirus (HPV) vaccine Gardisil is currently indicated for use in girls before they become sexually active, to prevent HPV infection. It is not known whether this vaccine may also be useful in women who already have HPV infection, and thus might work in a manner similar to investigational vaccines intended for other cancers (i.e., to treat rather than to prevent them).

Researchers from the National Cancer Institute, Bethesda, MD; Costa Rica; and the manufacturer conducted a study to determine whether an investigational HPV vaccine (bivalent HPV 16/18 virus-like particle AS04) will also treat pre-existing infections.

The phase III, masked, community-based randomized study conducted in Costa Rica involved 2,180 women aged 18 to 25 years who were positive for the presence of HPV at enrollment. The first group of 1,088 individuals received three doses of the HPV vaccine, and the control group of 1,101 infected young women received a hepatitis A shot.

Six months postvaccination, clearance rates for HPV-16/18 infections were 33.4% (82/248) in the HPV vaccine group and 31.6% (95/298) in the control group (vaccine efficacy for viral clearance, 2.5%). At 12 months, clearance rates of HPV-16/18 were 48.8% (86/177) in the HPV vaccine group and 49.8% (110/220) in the control group (vaccine efficacy for viral clearance, –2.0%).

The human immune system naturally clears some HPV infections over time, the researchers noted, as experienced in the control group. No added benefit was provided by giving women the HPV vaccine and no differences were seen between the groups in terms of viral antibody load, the extent of HPV-linked disease, or the results of cervical cell tests performed in the laboratory.


  Hildesheim A, Herrero R, Wacholder S, et al: JAMA 2007;298:743-753.





Docetaxel to Improve Clinical and Quality of LifeImprovement in the Treatment of Advanced Gastric or Gastroesophageal Cancer

Patients diagnosed with advanced gastric or gastroesophageal cancer are generally in need of not only clinical response but symptomatic relief. A phase III study was undertaken to determine if docetaxel, added to a regimen of fluorouracil and cisplatin (CF), improved not only clinical response but also patient’s symptoms.

Clinicians from the M.D. Anderson Cancer Center, Houston, Texas, reported the results of a multinational study comprising 445 patients with the conditions. The patients were randomly assigned to receive CF or docetaxel plus fluorouracil and cisplatin (DCF). Clinical benefit was measured as “time to definitive worsening” by one or more categories of Karnofsky performance status (KPS). Patient symptom relief was determined through changes in quality-of-life(QoL) measures.


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