Pfizer Animal Health today announced that the U.S. fda.gov/” rel=”nofollow”>Food and Drug Administration (FDA) has approved the first canine cancer therapy in the U.S. - PALLADIATM (toceranib phosphate) - which was developed by Pfizer to treat mast cell tumors in dogs. Pfizer made the announcement to veterinarians attending the 2009 American College of Veterinary Internal Medicine (ACVIM) Forum and Canadian Veterinary Medical Association Convention.

“Pfizer Animal Health is proud to bring the first canine cancer therapy approved by the FDA to U.S. specialists, their patients and caregivers,” said George Fennell, vice president, Companion Animal Division, Pfizer Animal Health. “In the weeks and months ahead, Pfizer will introduce PALLADIA to boarded specialists to expand the body of clinical experience with this new therapy. The experience gained during this time will enable us to support veterinarians more effectively when we make the product available for purchase in early 2010,” Fennell said.

Pet caregivers should continue to consult with their local veterinarians about options for their dogs with cancer, who may then refer appropriate cases to specialists for treatment with PALLADIA.

A new option to treat canine mast cell tumors

According to the Morris Animal Foundation, cancer is a leading cause of death in dogs. 1

Pfizer Animal Health estimates 1.2 million new canine cancer cases are reported in the U.S. every year. 2 Mast cell tumors are the second most common tumor type and are often seen as lumps in the skin. These tumors are classified as grade I, II or III, with grade III being the most severe. If not treated, they can spread to other parts of the body including lymph nodes.

Prescription-only PALLADIA is an oral therapy indicated to treat Patnaik grade II or III recurrent cutaneous mast cell tumors with or without regional lymph node involvement. PALLADIA belongs to the tyrosine kinase inhibitor (TKI) class of compounds. It works by blocking the activity of key receptors important for the development of blood vessels that supply tumors, as well as receptors critical for tumor survival.

“PALLADIA is an exciting, new treatment option for dogs with mast cell tumors,” said Cheryl London, DVM, PhD, board certified medical oncologist and associate professor at The Ohio State University College of Veterinary Medicine.

“At the completion of a PALLADIA clinical study, approximately 60% of dogs had their tumors disappear, shrink or stop growing. Also, we determined that dogs whose tumors responded to PALLADIA experienced an improved quality of life,”3 said Dr. London, who has helped Pfizer Animal Health’s Veterinary Medicine Research & Development to develop PALLADIA since 2000.

PALLADIA can be administered in a veterinary clinic or in the home by a dog’s caregiver. PALLADIA is not for human use and is only available in the U.S. Adverse events with PALLADIA can be serious but most are mild to moderate and are generally manageable. The most common side effects of PALLADIA involve the gastrointestinal tract and signs include diarrhea, decreased appetite, lethargy and vomiting. Life-threatening adverse events are rare but possible and early recognition is critical. Children should not come in contact with PALLADIA. In addition, all individuals, including children and pregnant women, should avoid direct contact with broken or partially-dissolved PALLADIA tablets or biological waste from dogs treated with PALLADIA. For specific dosing and prescribing information, visit http://www.palladia-pi.com.

About Pfizer Animal Health

Pfizer Animal Health, one of six business units of Pfizer Inc (NYSE: PFE), is a world leader in discovering and developing innovative animal prescription medicines and vaccines, investing an estimated $300 million annually. In 2007, Pfizer Animal Health began to expand its focus on pet oncology through a $1.1 million grant to the Morris Animal Foundation in support of an ongoing national canine tumor biospecimen bank. For more information on how Pfizer helps companion animals to live longer, healthier lives, or how Pfizer works to ensure a safe, sustainable global food supply with healthy livestock, visit http://www.PfizerAH.com.

About the American College of Veterinary Internal Medicine (ACVIM)

The ACVIM is the national certifying organization for veterinary specialists in large and small animal internal medicine, cardiology, neurology and oncology. The mission of the ACVIM is to enhance animal and human health by advancing veterinary internal medicine through training, education and discovery. For more information, please visit http://www.ACVIM.org.

1 http://www.CureCanineCancer.org

2 Pfizer Animal Health Market Research, New York, New York, data on file

3 London CA, Malpas PB, Wood-Follis SL, et al. Multi-center, placebo-controlled, double-blind, randomized study of oral toceranib phosphate (SU11654), a receptor tyrosine kinase inhibitor, for the treatment of dogs with recurrent (either local or distant) mast cell tumor following surgical excision. Clinical Cancer Research. Published online May 26, 2009 as 10.1158/1078-0432.CCR-08-1860.

Source
Pfizer Animal Health

CHICAGO, June 2 — Wireless capsule colonoscopy may eventually provide a safe, effective, and noninvasive alternative to the conventional colorectal cancer screening procedure, preliminary results of a multicenter study showed.

• Explain to interested patients that these findings came from an interim analysis of a not-yet-completed multicenter trial.
• Note that this study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

The method was well tolerated and detected polyps that were at least 6 mm in diameter in a similar number of patients (22% versus 21% with conventional colonoscopy), Jean-Paul Galmiche, M.D., of Hopital Avicennes in Bobigny, France, reported at Digestive Disease Week here.

The negative predictive value of capsule colonoscopy was 88% compared with the conventional technique.

But there were downsides as well, Dr. Galmiche said: good-to-excellent bowel preparation was achieved in only 55% of patients for the capsule technique, compared with 87% with conventional colonoscopy, and the sensitivity for detecting large polyps “was not optimal” at 55%.

Despite detecting a similar number of patients with polyps, conventional colonoscopy did not detect some polyps turned up by the capsule technique. Because the conventional method was considered the gold standard, some of the polyps discovered by the capsule method were considered false-positives, according to Dr. Galmiche.

However, he said, “it is clear that colonoscopy is not a perfect gold standard.”

Wireless capsule endoscopy has been successfully used to investigate the small bowel, and recently investigators have started using the technique to look at other parts of the gastrointestinal tract, including the esophagus and colon, Dr. Galmiche said.

The current study was an interim analysis of the first 105 patients in a 12-center study targeting an enrollment of 550 patients to test the noninferiority of wireless capsule colonoscopy in terms of negative predictive value.

Patients had a mean age of 60 and either a moderate risk of colorectal cancer — asymptomatic and between 50 and 74 years old (29%) — or a high risk (71%) — asymptomatic but with a personal or family history of polyps or cancer.

The capsule and conventional procedures were performed on different days.

To prepare, patients started a low-residue diet three days before the capsule colonoscopy. They ingested three liters of polyethylene glycol the day before, and an additional liter the morning of the procedure.

After the capsule was swallowed, the patients were given domperidone and sodium phosphate to ensure the progression of the capsule. Nine out of 10 patients excreted the capsule within 10 hours. That night, they ate a low-fiber snack.

Conventional colonoscopy was performed the next morning under general anesthesia after the patients consumed another liter of polyethylene glycol.

The safety and tolerability of the capsule technique was good, Dr. Galmiche said.

There were five adverse events. Three were considered mild or moderate and included hemorrhoids, fever, and bronchospasm. Two were considered severe — perforation during colonoscopy and cardiac failure possibly related to colon preparation.

None of them were attributed to the capsule.

On a visual analog scale for tolerability, patients rated the capsule technique as slightly better (8.80 versus 8.27, P<0.0001), although the statistically significant difference “is maybe not clinically relevant,” Dr. Galmiche said.

Colon cleansing was not as good during the capsule colonoscopy, possibly because of the amount of fluids that can be aspirated during a conventional colonoscopy but not during a capsule procedure, he said.

The sensitivity of the capsule technique for detecting polyps at least 6 mm in diameter was 55% compared with conventional colonoscopy. Specificity was 87%, the positive predictive value was 52%, and the negative predictive value was 88%.

Sensitivity and negative predictive value were increased when an expert panel reviewed the results.

Although the analysis established the feasibility, safety, and tolerance of wireless capsule colonoscopy, Dr. Galmiche said, improvements need to be made, including better bowel preparation, better training of capsule endoscopists, and improved capsules.

The study was funded by a grant from the French Ministry of Health. Dr. Galmiche reported no conflicts.

Primary source: Digestive Disease Week

Source reference:
Sacher-Huvelin S, et al “Wireless capsule colonoscopy compared to conventional colonoscopy in patients at moderate or increased risk for colorectal cancer: interim analysis of a prospective multicenter study” DDW 2009; Abstract 276.

A new surgical technique could allow surgeons to perform a radical hysterectomy in patients with early-stage cervical cancer-with fewer complications, reduced morbidity, and a lower risk of local tumour recurrence than current surgical methods, according to an Article published Online first and in the July edition of The Lancet Oncology.

The technique, called total mesometrial resection (TMMR), is a modified version of the traditional radical hysterectomy and involves more accurate, anatomically based resection of the cancer to prevent damage to the pelvic autonomic nervous system and to minimise surgical trauma.

For over 100 years radical hysterectomy has been the standard surgical treatment for early-stage cervical cancer. However, the procedure has a relatively high rate of tumour recurrence and many patients experience postoperative bladder and bowel dysfunction because of damage to the autonomic nerve system. In addition, postoperative radiotherapy-given as part of standard treatment-can have considerable unpleasant side-effects.

Current surgical practice is to remove the pelvic tissue adjacent to the tumour along with the cervix because of the risk of it harbouring cervical cancer. However, it has been suggested that local tumour spread may be restricted to the Müllerian compartment (fallopian tubes, uterus, and proximal, middle vagina and their embryologically defined mesotissues) for relatively long phases in its natural course, and that the removal of the complete Müllerian compartment in early-stage disease could improve local tumour control while reducing surgery-associated morbidity.

To improve on traditional radical hysterectomy and to show that the early stages of tumour growth are confined to the Müllerian compartment, Michael Hockel and colleagues assessed the effectiveness of TMMR without radiotherapy, in 212 patients with early-stage cervical cancer between 1999 and 2008 at the University of Leipzig in Germany. In this study, they report the histopathological tumour stages, resection margins, local recurrence, surgical morbidity, and 5-year outcomes of these patients.

Overall, findings showed recurrence-free survival of 94% and 5-year survival of 96%, with low treatment-related disease. At a median follow-up of 41 months only 10 patients had a recurrence of their cancer.

In addition, although 63% (134 patients) had high-risk histopathologic factors such as positive lymph-nodes and large tumour size, the overall recurrence rate was only 5%. This is considerably better than the 28% overall recurrence rate seen in similar patients treated with the normal surgical technique of radical hysterectomy. Indeed, the 5-year survival in patients with positive lymph-nodes was 91%, compared with previous reports in similar patients of 68-78%.

Importantly, 132 (63%) patients had no treatment-related complications, 75 (35%) had grade 1 complications, just 20 (9%) of patients experienced grade 2 complications, and no grade 3 or 4 complications were reported.

The authors say that: “Based on historical controls, TMMR without adjuvant radiation has the potential to improve survival by 15-20%.” They conclude by calling for further evaluation of the technique with multi-institutional controlled trials.

Link to article

Source
The Lancet Oncology