By: Ed Susman

SAN FRANCISCO, CA – Treatment of patients with anal cancer with a mitomycin C regimen provides a significant overall survival benefit compared with a cisplatin-based therapy, according to long-term follow-up of the Radiation Trials Oncology Group 98-11 phase 3 trial presented at the 2011 Gastrointestinal Cancers Symposium.

Although earlier reported results showed an improvement in colostomy failure with mitomycin C, the new analysis found that treatment with the drug in combination with radiotherapy had a statistically significant overall survival and disease-free survival benefit, said Christopher Willett, MD, Duke University Medical School, Durham, North Carolina.

After 5 years, 80 of the 325 patients treated with 5-fluorouracil plus mitomycin C, and radiation died during the 5-year period compared with 108 of 324 patients treated with 5-fluorouracil plus cisplatin and radiation (P =.021), Dr. Willett said in discussing his poster presentation.

He said the patients who received the mitomycin C treatment experienced 117 disease-free survival failures compared with 156 patients in the cisplatin arm (P =.0044).

“Concurrent radiation with 5-fluorouracil and mitomycin C has a significant impact on disease-free survival and overall survival,” Dr. Willett said. “Radiation plus 5-fluorouracil and mitomycin C remains the standard of care for patients with anal canal carcinoma.”

The researchers also determined that being a man, presenting with tumours >5 cm in diameter, and having lymph node positive disease are all independent poor prognosis factors of overall survival and disease-free survival in anal cancer.

Dr. Willett said the researchers also noted that there were trends which did not achieve statistical significance in favour of mitomycin C for local/regional recurrence control (P =.089); colostomy-free relapse (P =.053); for colostomy failure (P =.075); and for distant metastases (P =.12).

The researchers originally enrolled 682 adult patients into the study; 649 were included in the analysis.

- MFP Wire Services
- 01-31-2011

By: Ed Susman

SAN FRANCISCO, CA – A retrospective study that evaluated the use of yttrium-90 microspheres to embolise arteries feeding metastatic liver tumours in patients with advanced colorectal cancer indicate that the best outcomes are achieved in patients whose cancer spread is limited to the liver, researchers said at the 2011 Gastrointestinal Cancers Symposium.

More than half of these heavily pretreated patients who achieved >1 year survival had only metastases in the liver when they underwent treatment with yttrium 90, said Marisa Hill, MD, Northwestern University, Chicago, Illinois, during her poster presentation.

“Yttrium-90 may represent a viable palliative treatment option for these patients with unresectable liver metastases,” Dr. Hill said.

Dr. Hill and colleagues reviewed outcomes of 36 patients who underwent the computer-assisted tomography-guided endovascular placement of the microspheres in hepatic arteries. The median overall survival for the group of patients was 9.9 months following the procedure.

But she pointed out that among the 16 patients who had no extrahepatic lesions; the median overall survival was 13.8 months. The median overall survival for the 20 patients with extrahepatic lesions was 6.9 months.

Dr. Hill also noted that the performance status of the patients was also a factor in longer survival. Those 23 patients with a performance status of 0 had a 14.8-month median survival. On the other hand those who had a performance status of 1 or 2 achieved an overall median survival of 5.8 months.

The patients in the study had a median age of 58 years and 20 of the patients were men. They had all received treatment courses that included irinotecan, oxaliplatin, and 5-fluorouracil. The patients had undergone the procedures at Northwestern from 2001 to 2009.

“Survival data for the population of liver-only metastatic disease and for those with Eastern Cooperative Oncology Group Performance Status of 0 treated with yttrium-90 compare favourably with published survival data in the third-line treatment of colorectal cancer,” Dr. Hill said. “Further study of the use of yttrium-90 for liver metastases from colorectal cancer should focus upon this population.”

- MFP Wire Services
- 01-31-2011

By: Ed Susman

SAN FRANCISCO, CA – A vitamin K1-based cream appears to control the characteristic acne-like skin rash often observed among patients with cancer treated with anti-epidermal growth factor receptor agents such as cetuximab, researchers said at the 2011 Gastrointestinal Cancers Symposium.

“We saw either a reduction in the rash or control of the rash in about 705 of our patients,” said Carlo Pinto, MD, S. Orsola-Malpighi Hospital, Bologna, Italy, at his poster presentation. “We are now planning a study to see if this treatment can be used prophylactically to prevent skin rashes in these patients.”

“Cutaneous toxicity, and especially skin rash, is a predictable side effect of anti-epidermal growth factor receptor monoclonal antibody therapy,” he said. “Previous studies have shown that vitamin K1 reactivated epidermal growth factor receptor-mediated signal transduction after inhibition via epidermal growth factor receptor antagonists.”

Dr. Pinto and colleagues set out to determine if use of vitamin
K1 cream could control the rash in these patients.

At the onset of grade 2 or greater skin rash, the 22 men and 11 women in the study were told to use the cream in affected areas twice a day, Dr. Pinto said. The patients were treated with either cetuximab or panitumumab for metastatic cancer of the oesophagus, colon/rectum, or head and neck. The topical treatment
with vitamin K1 (phytomenadione 0.1%) was administered continuously until the end of anti-epidermal growth factor receptor treatment — an average of 24 weeks.

The study was conducted from February to September 2010. Twenty-six of the 33 patients were treated with cetuximab, while the other 7 patients were treated with panitumumab. Platinum-based regimens were administered to 23 patients; 6
received irinotecan-based therapy, and 4 patients were treated with panitumumab monotherapy.

Dr. Pinto said 12 of the patients were able to reduce the skin rash to a grade 1 category, and 13 other patients had no further skin changes. An increase to grade 3 in skin rash was observed in 8 patients.

“Good skin rash symptom control was obtained in 69.2% of patients,” Dr. Pinto said. “These preliminary results suggest a favourable impact of vitamin K1 cream in skin rash management, which should be considered in a future clinical trial.”

He said the control of rash was important because it appeared to be associated with improved treatment compliance.

- MFP Wire Services
- 01-29-2011