The Australia and New Zealand Sarcoma Association (ANZSA) has been conducting clinical trials to investigate effective treatments for sarcoma—a rare form of cancer which starts in bone and soft connective tissue. Only 1% of all cancer is sarcoma and there are more than 100 subtypes of sarcoma.
Being such a rare disease, current sarcoma treatments aren’t particularly well investigated. In fact, presently there has been no significant change in therapy to improve overall survival for patients with this type of cancer in the past decade.
Challenges arise with the investigation of rare diseases. Patient recruitment is difficult since the cancer is rare and the multiple subtypes of sarcoma. To recruit enough patients to a large randomised trial , we often have to involve international counterparts. ANZSA has embarked on an international collaboration with the Sarcoma Alliance for Research through Collaboration (SARC), a US-based not-for-profit organisation with a focus on sarcoma research.
This collaboration has resulted in the development of the SARC032 trial—a randomised phase II trial which aims to examine the role of adding immunotherapy (pembrolizumab) to standard treatment of radiotherapy and surgery in high grade soft tissue sarcoma of the extremity. The trial has been underway for a year and is currently recruiting.
Principal Investigator, Professor Angela Hong, says she is a firm believer in synergetic effect of combining radiotherapy and immunotherapy; one of the aspects that make SARC032 unique.
Novelty of SARC032
The treatment involves local treatment with radiotherapy and surgery. The patients in the trial have immunotherapy, preoperative therapy, standard surgery six weeks later, and then more immunotherapy.
Patients have a pre-op biopsy to confirm diagnosis of sarcoma, and then an optional, local, on-treatment biopsy during immunotherapy.
“By looking at the tissue sample, we hope that we can identify an additional prognostic marker and additional markers to predict patient response to radiotherapy and immunotherapy. So that is a really nice translational element of our study that sets our trial apart.”
“There’s also no other trial in Australia that looks at patients with this stage of the disease. So the only way for patients to get access to this treatment and the concurrent radiotherapy is through recruitment in this trial,” said Prof Hong.
The Effects of COVID-19
While many trials have been negatively affected by COVID-19, all ANZSA trials have managed to carry on.
“Because this cancer is so rare and aggressive, we believe the best option for patient care is clinical trial participation. But we have had to adapt with Telehealth, especially as many of our patients come from a long distance away from the specialised sarcoma centres.” Said Prof Hong.
Surgeons have also had to adapt by operating on patients at different hospitals due to the allocation of ICU beds to COVID19 patients, which has meant a fresh wave of ethics and governance approval. The radiotherapy scheduling was literally modified and approved by SARC overnight to reduce the number of radiotherapy fraction. ANZSA has also had to modify pathology systems by taking fresh frozen samples and ship them to the US.
ANZSA has two mechanisms for consumer involvement: a consumer advisory panel chaired by a patient advocate, which reviews and advises new trial concepts, and promotes and distributes trial information to the sarcoma community. The chair of consumer advisory panel is also a board director of ANZSA. There are two patient advocates on the ANZSA scientific advisory committee (SAC). The SAC is the engine room for trial and research activities, as all new research concepts from basic lab research to clinical trials are discussed at scientific advisory committee. The committee also includes a multidisciplinary mix of clinicians ; adult and paediatric oncologists, and basic science researchers.