Chemoradiation for pancreatic cancer better

The addition of the drug gemcitabine with chemoradiation for the therapy of patients who had surgery for pancreas cancer was linked to a survival benefit, eventhough this improvement was not statistically significant, as per a research studyin the March 5 issue of JAMA.

Despite the potential benefits of surgically removing cancer involving the pancreas, there is a 50 percent to 85 percent rate of local relapse linked to liver and intra-abdominal failure and a 5-year survival of less than 20 percent, as per background information in the article. The frequency and pattern of failure makes the combination of added postoperative chemotherapy and radiation an important consideration. The drug gemcitabine has been shown to improve outcomes compared with the drug fluorouracil.

William F. Regine, M.D., of the University of Maryland Medical Center, Baltimore, and his colleagues conducted a study to assess if the addition of gemcitabine to the supplemental therapy of fluorouracil chemoradiation (chemotherapy plus radiation) improved survival for patients who had a portion of their pancreas removed as a therapy for pancreas cancer (surgical resection). The randomized controlled phase 3 trial included 451 patients enrolled between July 1998 and July 2002 at 164 U.S. and Canadian institutions, with follow-up through August 2006. Patients received chemotherapy with either fluorouracil (n = 230) or gemcitabine (n = 221) for three weeks previous to chemoradiation treatment and for 12 weeks after chemoradiation treatment (with fluorouracil).

The scientists observed that patients with pancreatic head (a part of the pancreas) tumors (n = 388) had a median (midpoint) survival of 20.5 months and 3-year survival of 31 percent in the gemcitabine group vs. 16.9 months and 22 percent in the fluorouracil group. A certain level of hematologic (involving abnormalities in the blood cell counts) toxicity (grade 4) was 1 percent in the fluorouracil group and 14 percent in the gemcitabine group without a difference in neutropenia (a blood disorder) or infection. There were no differences in the ability to complete chemotherapy or radiation treatment.

The addition of gemcitabine to [supplemental] fluorouracil-based chemoradiation was linked to a survival benefit for patients with resected pancreas cancer, eventhough this improvement was not statistically significant, the authors write.

Patients in the study had the lowest rate of cancer recurring in its original location than in other prior studies. The tumor came back in the same area in 23 percent of the patients, in comparison to 40 percent to 60 percent of patients in other studies. At least 70 percent of the patients in this study experienced spread of their cancer to other parts of the body, a process that is known as systemic metastasis.

Laboratory correlative studies from [this trial] are ongoing and are evaluating molecular genetic alterations that promote local and systemic relapse. Future trials should emphasize novel systemic therapys to reduce systemic metastases and modern image-guided radiation to prevent local recurrence while reducing radiation-correlation toxic effects.

(JAMA. 2008;299[9]:1019-1026. Available pre-embargo to the media at www.jamamedia.org).

Editors Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Adjuvant Therapy for Surgically Resected Pancreatic Adenocarcinoma

In an accompanying editorial, James L. Abbruzzese, M.D., of the University of Texas M. D. Anderson Cancer Center, Houston, offers suggestions on how to improve outcomes for pancreas cancer patients with surgical resection.

First, the lessons regarding the optimal selection of patients for surgical resection need to be exported more effectively into the high-surgical volume setting. Second, further work is needed to determine which patients are most likely to benefit from chemoradiation and, if this modality is going to evolve, further emphasis should be placed on the development of more effective radiation sensitizers.

Third, based on interindividual differences in drug metabolism and DNA repair, it appears that patients who are more likely to benefit from current chemotherapy and chemoradiation strategies can be defined prospectively. These individualized approaches should be examined in prospective clinical trials.

Finally, and most importantly, efforts must be redoubled to develop a new generation of promising therapeutics, and the commitment must be increased to understand and test them in prospectively defined patient subsetsnot the means to detect marginal or incremental improvements in clinical trials of large numbers of unselected patients.

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The smaller the tumor, the better your chances

The odds of surviving cancer of the pancreas increase dramatically for patients whose tumors are smallest, as per a new study by scientists at Saint Louis University and the M.D. Anderson Cancer Center in Houston the first study to specifically evaluate the link between tumor size and survival rates for one of the most common and deadly cancers.

The findings in the current edition of Pancreas (www.pancreasjournal.com) vividly underscore the importance of early diagnosis of pancreas cancer, the scientists said.

Even though it seems intuitive and was supported by preliminary observations from earlier studies, for the first time we now have evidence that a progressive decrease in the size of a pancreatic tumor at the time of diagnosis improves patient outcomes rather dramatically, said Banke Agarwal, M.D., Associate Professor of gastroenterology at the Saint Louis University School of Medicine and lead author of the study.

These data emphasize the benefit and the need of finding and diagnosing tumors in the pancreas as early as possible, Agarwal added. In order to make progress against pancreas cancer, we have to redouble our efforts to identify symptoms that are linked to the early stages of the disease.

Pancreas cancer is the fourth most common cancer in the United States and one of the most deadly, responsible for more than 33,000 deaths a year, as per the National Institutes of Health.

Despite a number of advances in the fight against other cancers in recent years, the prognosis for patients diagnosed with the pancreas cancer has remained extremely poor. Thats largely because the cancer is frequently not suspected and is difficult to diagnose in its early stages, when most people are asymptomatic or have non-specific symptoms that are easily ignored or attributed to other diseases.

The study looked at 65 patients who were diagnosed with pancreas cancer at the M.D. Anderson Cancer in Houston between December 2000 and December 2001. Their average age was 67 years old; 38 were men.

Scientists found a striking connection between a patients prognosis and the size of their tumor at the time of diagnosis.

Of the 12 patients whose tumors were 20 millimeters or smaller, their median survival after diagnosis was 17.2 months. For those with tumors 21-25 mm, median survival was 12.3 months. For those with tumors 26-30 mm, median survival was 8.5 months. And for those with tumors larger than 30 mm, median survival was 7.6 months. Of those patients whose tumors were 20 mm or smaller, two were still alive after 48 months; none of the patients with tumors larger than 30 mm were alive after 36 months.

Unfortunately, while the patients with the smallest tumors had the highest rates of survival, they were relatively small in number. Only 12 patients or 18 percent had tumors 20 mm or smaller. By contrast, the largest group of patients 27, or 42 percent had tumors larger than 30 mm.

In addition, the average tumor size of patients in the study was 32.9 mm well above the threshold at which survival rates are lowest. That figure is roughly comparable to an average tumor size of about 30 mm among pancreas cancer patients in general, as per the study.

These numbers illustrate why weve made so little progress in improving outcomes for people who are diagnosed with pancreas cancer were not finding their tumors until theyre too big and its too late, Agarwal said. We know we have a much better chance of helping someone survive pancreas cancer if its caught early and their tumor is small.

Major advances in imaging technology in recent years have greatly improved physicians ability to diagnose progressively smaller pancreatic tumors. This hasnt led to earlier diagnosis, however, because patients generally dont get to the doctor until symptoms appear and by then its too late.

Agarwal said scientists will need to focus on finding ways to identify people who should be screened early for pancreas cancer. Screening of the general population for the disease hasnt proven effective but screening of people with a family history of pancreas cancer is under active investigation, he said.

In addition, preliminary data from other studies have shown that elderly people whove been recently diagnosed with diabetes or depression have a higher likelihood of pancreas cancer providing another avenue for scientists to explore, Agarwal said.

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