Standard drugs, some used a second time, in safe novel low dosages, produce unexpected responses.
NEW YORK, Oct. 10, 2013 /PRNewswire/ -- The following will be presented at the 18th World Congress on Controversies in Obstetrics, Gynecology and Infertility (COGI) in Vienna, Austria October 24-27, 2013. This prospective effort expands the number of resistant ovarian and endometrial cancer eligible for "high value" treatments-for responses which allow neoadjuvant, curative, surgery and intraperitoneal therapy. A core combination of available drugs can reverse a tumor's resistance to many additional drugs and can impact the common failure to provide patients with life saving treatments. The importance of correcting this major systemic health care failure was highlighted at the 2013 Los Angeles Women's Health Conference and in The New York Times columns and Editorial pages on March 11 and 13, 2013. It is feasible that palliative treatment can be replaced with serial addition of available drugs to the core to allow curative further treatments. The Core regimen allows strategies which can safely double the value and applications of targeted biologic therapy. Such treatments are needed for 200-600 (additional) patients every day.
In a sample of 30 patients, the drug pair of Avastin and Cyclophosphamide (ACy), when added to the core produced an overall 83% response rate and significant rates of response for patients, with the most difficult subclasses of resistant tumors (overall 75% previously failed many of the core drugs, and 25% were initially considered too sick to treat). ACy and the core, Gemcitabine, Fluorouracil, Irinotecan, Carboplatin -/+ Docetaxel (GFLIC D), in safe, ½ - ¼ of standard dosages also improved benefit and subset survival in a statistically significant fashion:
1) Early use of this regimen, at first evidence of failure, doubled the prior best rate of complete response for five out of five patients with primary platinum resistant tumors.
2) Late use, for heavily treated patients, doubled overall response rates,
3) Responses produced "high value" opportunities for neoadjuvant, potentially curative, treatment. Seven out of seven, 2-6cm size tumors in a row were reduced to neoadjuvant eligible size "after five prior treatments had failed,"
4) Responses increased median relapse free survival, two fold and more, 12 months and more, for both heavily treated and sick patients, and lastly,
5) Responses corrected severe complications five-fold better than expected. Seven out of 8 times, partially bed bound "crises" patients, resistant to five treatments; achieve symptom free status. (Too often these patients are not offered any treatment). There are no standard treatments for such patients with similar rates of benefit or objectives.
The rates of responses already satisfy Phase II feasibility criteria. They challenge conventional limitations placed on eligibility of patients and outcome objectives. However, this treatment is neither a substitute both for primary standard treatments nor consultation with an expert familiar with the patient, the disease and the drugs.
Sources: Bruckner and others: ASCO 2001 Pancreatic cancer; ASCO 2006 Gastric cancer; ASCO 2008 and 2012 Pancreatic cancer and ASCO 2012 Cholangiocarcinoma, bile duct cancer, describe the development of these multi-mechanism five-way biochemical modulating and five-way metronomic regimens.
The presenter, Howard W. Bruckner MD, a former professor, author of 150 plus publications and 200 more abstracts, was the first to describe the use of platinum for ovarian cancer (ASCO) and high dose platinum.
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