Welcome to March. This issue features medical information that might be of interest to kidney cancer patients and their families. Apologies if some of this sounds like gobbledy gook in places. If you have questions, please just ask.
On behalf of Kidney Cancer Canada and the International Kidney Cancer Coalition, I had the opportunity to attend GU ASCO (Genitourinary Cancers Symposium hosted by the American Society of Clinical Oncology).
Many oncologists who specialize in kidney cancer attend and present research updates at this annual meeting. Please note that these highlights are written from a patient advocate’s perspective. I am not a medical professional, but I have a keen interest in kidney cancer. If you have questions that pertain to your own case, please consult with your physician.
Ok. With that disclaimer done, here’s what I found to be new and interesting to the kidney cancer patient community:
Adjuvant Treatment Has Proven Unsuccessful
The ASSURE trial, presented by Dr. Naomi Haas: this was a clinical trial of sunitinib (Sutent) vs sorafenib (Nexavar) vs placebo in the Adjuvant setting (post-nephrectomy, higher risk, but with no visible metastasis). Some 25% of patients required down-dosing due to toxicities. Accrual was faster than expected with some 1943 patients from Canada and the U.S.
Unfortunately the results showed that these medications taken in this setting do not affect the likelihood or timing of recurrence. While this is disappointing news, it’s important for everyone to know and we all owe a HUGE thank you to those patients and their families for helping us better understand when to use (and not use) the current medications. Other Adjuvant trials are ongoing with other agents and will report in future conferences. Because this trial collected tumour and blood samples, every single participant has contributed to building a database so that researchers can continue working. On behalf of all of us, thank you for participating in this really important trial.
Net: The standard of care for patients following nephrectomy has not changed. Patients (who are not on a clinical trial) should be followed closely as per our national guidelines.
None of the immuno-oncology drugs is yet FDA-approved for renal cell carcinoma — potentially the first will be later this year and approved in the 2nd line IF that trial is successful, or could be 2016. Some interesting clinical trials are now underway in every form of cancer, including kidney cancer. Important to note that these treatments have a very different side effect profile – can affect any organ system and create “any-itis” including pancreatitis, pneumonitis, arthritis, colitis. Can range from completely asymptomatic to very severe. Patients will need to be educated about early intervention and reporting. Noted: “1 day in reporting your symptoms could be 1 extra week in the hospital”. Some severe toxicities have been noted, particularly in combination trials. Important for patients to be enrolled in clinical trials where there is expertise in immuno-oncology (from melanoma experience, HD-IL2 experience, etc.)
Complete Responses and Drug Holidays
Complete Responses and Drug Holidays with VEGF-TKIs (Dr. Laurence Albiges): Interesting presentation for those patients who achieve a Complete Response (CR). Of 112 patients, the average time on treatment to CR was 12-18 months on treatment. To confirm a CR, the recommended approach was to wait until you have 2 CT scans, a minimum of 3 months apart, with no visible disease. At that point, a drug holiday could be started (median break duration was 16.8 months). The response rate at treatment re-challenge (either with the same or a different VEGF-TKI) was 66-87%.
Net: We have all met patients who are “NED” (No Evidence of Disease). There has been some discussion about whether these patients should stay on drug or take drug holidays. This study provides some guidance.
Drug Holidays: an interesting study is ongoing in the UK (STAR trial, Dr. Janet Brown) with 1000 patients with two streams. Everyone receives 4 cycles of a TKI (either sunitinib or pazopanib – patient choice) and then either continues with the drug OR takes a treatment break until progression (and then restarts for 4 cycles). This is an important study that could offer Quality of Life benefits as well as health economic benefit if successful. Dr. Brown reported that the study has 340 patients to date.
Non-Clear Cell RCC
Dr. Marston Linehan (NCI/NIH) made a clear point that kidney cancer is not kidney cancer. There are at least 20 different types, at least 15 different genes/types identified already. For papillary rcc, there are some promising studies at the NIH:
- Avastin + Tarceva: trial will be expanded later this spring to be able to accept more patients. Achieving durable patient response (some patients now at 3 years+).
- INC280 (MET inhibitor) trial ongoing:
Elsewhere there are various trials for papillary mrcc patients with MET inhibitors, including this one being offered in Canada.
Some Interesting Clinical Trial Results and Progress Updates
- SBRT: Dr. Patrick Cheung from Sunnybrook (Toronto) presented on SBRT (stereotactic body radiation therapy) for oligo-metastasis — isolated spots of metastasis where the goal is to eradicate all visible sites of disease. This technology is achieving high local control rates of disease (70-90%) for rcc tumours and can be applied to virtually any body site now. Also discussed this clinical trial opening at centres across Canada for “oligo-progression” – to determine whether the use of SBRT while on sunitinib can treat rogue tumours and extend time on treatment.
- DART study – goal is to see whether the activity of a VEGF-TKI (in this case axitinib/Inlyta) can be extended by adding an ALK1 inhibitor (dalantercept). This study is accruing in 30 centres across the U.S. See here:
- Sarcomatoid RCC & Poor Risk RCC – Dr. Rana McKay presented positive findings for a trial of sunitinib plus gemcitabine for those with rapidly progressive disease. (Important study for those with sarcomatoid >10% in their pathology). Gemcitabine is a chemotherapy agent that can improve disease control in particularly aggressive disease such as sarcomatoid. Other trials with chemotherapy are underway for this subset of patients.
- Thomas Powell (UK) presented on a new TORC1/TORC2 P13K inhibitor (AZD2014) that proved to be inferior to everolimus (Afinitor). This trial was closed quickly as soon as the data began to emerge and patients were switched to the standard of care early. Dr. Powell made a sincere and heart-felt thank you to the patients and their families for taking part.
Some Take-Home Messages:
Overall, I wish that more patients could see the room packed with hundreds of oncologists discussing and learning about kidney cancer. Absolutely no one is resting with what we have available today:
- We need to know more about active surveillance vs treatment start, individualized dosing and quality of life with current treatments
- We need to better manage toxicities (side effects) of current drugs and especially with immuno-oncology treatments
- We need biomarkers to direct therapy & better drugs that will prevent recurrence.
Will conclude with some words from Dr. Tony Choueiri: “We do all of this for our patients. I do firmly believe that they deserve a cure.”
For more information on the entire conference, please see here: