Outlook: Clinical Trials

Pharmacy Times, Volume 0, 0

Ms. Farley is a freelance medical writer based in Wakefield, Rhode Island.

Hope for Patients with Pancreatic Cancer

The survival rate for patients with pancreatic cancer could possibly double whengemcitabine (Gemzar) is used after surgery, according to a recent study. Pancreaticcancer is considered one of the deadliest cancers, offering patients a dire prognosis—made worse by the fact that it is often not diagnosed until it is too late for effectivetreatment. The downside of gemcitabine's postsurgery efficacy is that only about 15%of patients with pancreatic cancer are surgical candidates. Currently, gemcitabine isthe standard treatment when pancreatic cancer cannot be surgically removed.

Survival Without Recurrence

Overall Survival

3-year Mark

5-year Mark

5 years

>5 years

Gemzar

23.5%

16.5%

36.5%

21%

Placebo

7.5%

5.5%

19.5%

9%

Researchers expect widespread adoption of gemcitabine in the treatment of postsurgerypancreatic cancer. Study results were presented at the American Society ofClinical Oncology's annual meeting in Chicago this past May.

Chemo Drug Equals Effectiveness of Radiation

The most common cancer in men aged 15 to 45 is testicular cancer, with the standardtreatment being surgery followed by radiation. A recent study, however, hasshown that a single dose of the chemotherapy drug carboplatin is just as effectiveas radiation therapy but not as toxic. A randomized study included 573 patients whoreceived a single dose of carboplatin dosed over 1 hour on an outpatient basis and904 patients who received daily radiotherapy over a 2- to 3-week period. The 5-yearmark showed similar cancer recurrence rates in both groups: 5% in the carboplatingroup and 4% in the radiation group.

Test PinpointsWho Benefits fromCancer Drug

Study results presented at the MayAmerican Society of Clinical Oncologyannual meeting reveal that, with coloncancer, physicians can now determinewhich patients will benefit from thechemotherapy drug cetuximab (Erbitux).By using a KRAS test, clinicianscan pinpoint which patients have thenormal version of a particular gene andknow that those patients will benefitfrom treatment with cetuximab, whichhas been approved as an addition tochemotherapy—but only for patientswith the normal version of the gene.Researchers reviewed tumor samplesfrom 587 patientsand found that thosewith normal KRAS genes had a 32%reduced risk of cancer recurrence,comparedwith 15% for all patients.Knowing who should receivethe drugbeforehand may indicate the future ofcancer treatment—tailored or personalizedtherapy for patients.

Erbitux Offers Small Hope in Lung Cancer Battle

Researchers have found that thecancer drug cetuximab (Erbitux), whencombined with chemotherapy, extendsthe life of patients with advancednon?small-cell lung cancer (NSCLC) by about5 weeks. In the lung cancer arena,it is important to note that prognosisis still very poor, and the 5-year survivalrate is less than 5%. In fact, otherclinical trials have shown cetuximab tohave no benefits, and this trial is onlythe second one to show any positiveresults. Cetuximabacts like bevacizumab(Avastin) by cutting off a tumor'sblood supply. Bevacizumab, it shouldbe noted, is the only approved targetedtherapy for NSCLC. The study that yieldedthese results included 1125 patientswith stage IV cancer randomized toplatinum-based chemotherapy aloneor chemotherapy plus cetuximab. Thecetuximab group lived 11.3 months onaverage, compared with 10.1 months inthe chemotherapy-only group.

Cancer Pain Drug May Reduce Intensity

Phase 3 trials have been completed for BEMA Fentanyl inthe treatment of "breakthrough pain" (BTP) in cancer patientswho can tolerate opioids. The drug is a small, dissolvable filmcontaining fentanyl that is applied to the inner lining of thecheek membranes. In the study, 81 patients received BEMAFentanyl and placebo in a random order to treat their BTPepisodes. Altogether, 394 BTP episodes were treated withBEMA Fentanyl, and 197 were treated with placebo. The endpoint was to determine the sum of pain intensity difference at30 minutes; the difference in pain intensity was significantly(and positively) higher when the patient took BEMA Fentanyl.The long-term study included 220 patients and more than56,000 BTP episodes. The average dosage was 2.9/day for112 days.

Side Effects

Nausea

8.6%

Dizziness

5.5%

Constipation

5.0%

Drowsiness

4.5%

Manufacturers are awaiting an August 2008 decision on theirnew drug application.