Fast track new drug trial

FDA Places PC14586, for Cancers with Mutant Protein, on Fast Track

https://tinyurl.com/y5kv3utz

 

         Of recent times there has been a concentration on the treatment of ovarian cancer resulting from inherited or germ line mutations. High Grade Serous Ovarian Cancer is the commonest and most lethal, this is associated with an acquired or somatic mutation (TP53) in about 97% of cases.

          Now for the first time, a recent determination, by the Federal Drug Agency to fast-track acceptance for investigation of a new drug; PC14586, raises the prospect of a remedy for this somatic mutation.

         This drug is to be tested through a Phase I/II trial looking to establish its safety and effectiveness.   As with all clinical trials, the likelihood of progression to standard treatment is less than 2%. 

Ovarian tissue preservation

Breaking down the barriers: a new collaborative model providing fertility care for young cancer patients

https://tinyurl.com/y6t5jhuu

 

         Loss of fertility is of great concern to young women who undergo surgery and chemotherapy for cancer. Risk reduction surgery is now offered to those women who have an increased risk of ovarian cancer due to genetic predisposition.

         For pre-pubertal girls cryopreservation of ovarian tissue may be the only way to preserve fertility. There has been difficulty in access for patients outside major centres.

         A long-standing Fertility Preservation Service has been available in Melbourne. This has now been expanded to provide a nation-wide tissue retrieval and transportation service.

         Fertility preservation should be mandatory in cancer care; this new service makes it possible for all young people who need it.

 

Dangerous misunderstanding

Tackling misconceptions about ovarian cancer 

https://tinyurl.com/y58cmcfu

 

         With ovarian cancer early detection is critical for better survival. Because there is no screening test a high index of suspicion by women is essential. Adequate education as to symptoms and signs is needed.

         This study performed in Melbourne, Australia was a telephone survey of almost 500 women looking at their understanding of ovarian cancer.

         The results were alarming; 65% thought there is an effective screening test and that a PAP smear was used to detect ovarian cancer, 50% thought that a vaccine is available to prevent ovarian cancer. All these assumptions are incorrect. 

         Confusion regarding the vaccine is thought to be a result of the high numbers of women who have been immunised against HPV to prevent cervical cancer (90% uptake in Australia).

Darwinian chemo

 

Preventing drug resistance to PARP inhibition in ovarian cancer through novel dosing regimens based on cancer evolutionary dynamics

https://tinyurl.com/yymjfer6

 

         The historical use of chemotherapy has been an attempt at elimination, looking to cure. However, for many tumours including ovarian cancer there is high recurrence rate often associated with resistance to the first-line drug therapy.

         The development of drug resistant cancer may be an evolutionary process with survival of the fittest, being the evolution of a cancer clone to resist chemo. This preliminary report of an on-going PhD project addresses the issue of resistance to PARP inhibition.

         Evolutionary dynamic theory aims to control rather than eliminate cancer, the idea being that stop-start intermittent treatment will prolong the effectiveness of the enzyme inhibition, which is the mechanism of PARPi maintenance, thereby delaying cancer recurrence.

Replicate & Confirm

Real-World Outcomes of Olaparib for Relapsed BRCA Ovarian Cancer Consistent with Previous Trials

https://tinyurl.com/y38jzscg

         

         

      With any new therapy or drug treatment there is a honeymoon period of great enthusiasm and hope. This can be exaggerated by the results of Clinical Trials, which may emphasise positive results and present them in a manner calculated to increase sales.

         Fortunately scientific method assists to determine the true impact of trials by replication and confirmation. This article looks at a real-world study of 128 women with relapsed ovarian cancer who were treated with Olaparib as part of normal therapy and compared the outcomes with the published trial results (SOLO III).

         The SOLO III trial examined the effect of Olaparib treatment for ovarian cancer patients who relapsed after initial chemo and surgery. Its main finding was an improved median Progress Free Survival (PFS) of 30 months compared to 5 months with placebo. For the real-world study the median PFS was 15.5 months.

         Significant side effects were noted with almost 12% of the patients having to discontinue the treatment. The authors suggest the outcomes are consistent with the results of SOLO III.