Clinical Trials: From the Editor

08 September 2017

It is fortunate that we cure the vast majority of men with testicular germ cell tumors.  Estimates show that only approximately 10% of men with metastatic Stage III germ cell tumors are not cured.¹  The bad news if that for those who aren’t cured with standard dose combination cisplatin-based chemotherapy with or without eventual high dose chemotherapy with autologous stem cell rescue (stem cell transplant), there are few options.  Palliative chemotherapy is often limited in efficacy, and regimens such as gemcitabine with oxaliplatin have been used.²  

14 August 2017

Early attempts at checkpoint inhibition in prostate cancer seemed to offer little promise.  The initial trial with CTLA-4 inhibition with ipilumumab was performed in patients with metastatic castration-resistant prostate cancer (mCRPC) in the post-docetaxel setting and resulted in a HR 0.85, 95% CI 0.72-1.00; p=0.053.¹ 

14 July 2017

For the longest time metastatic hormone-sensitive prostate cancer has been treated with androgen deprivation therapy (ADT).  Recently, the CHAARTED¹ trial and STAMPEDE,² both showed a dramatic survival benefit when 6 cycles of docetaxel was added to ADT.  For the CHAARTED trial, subgroup analyses confirmed survival benefit for those patients with high volume disease, defined as ≥4 bone metastases with at least one in the appendicular skeleton and/or a visceral metastasis. 

08 June 2017

For the past few years, most patients have received sunitinib¹ or pazopanib² for new metastatic clear cell renal carcinoma.  Yet, the National Comprehensive Cancer Network (NCCN guidelines)³ also provide other preferred category 1 options in bevacizumab + interferon⁴ and temsirolimus⁵ specifically for those patients with poor prognostic features. 

18 May 2017

On May 10^th, 2017, a shocking thing happened.  A trial that most everyone assumed was a slam-dunk for a phase 3 trial in metastatic or locally advanced urothelial carcinoma bounced off the rim, as it failed to meet its primary endpoint of overall survival.  This trial utilized atezolizumab vs. a taxane in the prior platinum treated setting, with the intention of sealing the victory after atezolizumab gained accelerated FDA approval for response rate and durability of response for this patient population approximately a year ago. 

11 April 2017

With the recent regulatory approvals of PD-1 and PD-L1 antibodies for patients with metastatic urothelial cancer, we have significantly expanded treatment options for this patient population.  Atezolizumab is a PD-L1 antibody that not only demonstrated significant responses but has also shown durability of response and clinical benefit through stable disease in a substantial proportion of patients in the post-platinum treated setting, leading to FDA approval in May 2016.¹ 

14 March 2017

Non-metastatic (M0) castration-resistant prostate cancer (CRPC) is truly a misnomer.  It is meant to highlight a prostate cancer disease state that solely exists because of the use of prostate-specific antigen (PSA).  In most fields, patients either have localized disease or radiographically-detectable metastatic disease.  Since PSA is a highly sensitive measure of detection, our field is able to detect microscopic metastases due to limits of standard imaging modalities. 

12 February 2017

Recent genome sequencing data in metastatic prostate cancer have led to some significant changes in how we think about advanced disease. Namely, the Stand Up 2 Cancer (SU2C) International Dream Team discovered that 23% of patients with metastatic castration-resistant prostate cancer harbor genetic alterations in genes that lead to homologous recombination deficiency (HRD) e.g. BRCA2, BRCA1, ATM, etc.¹ Even more recently, our group at the University of Washington together with others have found 11.8% of patients with metastatic prostate cancer, both hormone-sensitive and castration-resistant, to harbor germline alterations in DNA repair genes.² Interestingly, there was no clear association with patients diagnosed at a younger age or those with a family history of cancer. This has great implications, not only for possible therapeutic options but for genetic and family counseling.

15 December 2016

Oncology allows for a rare opportunity to connect deeply patients and families—from the outset of treatment, through the course of the disease, sometimes over several years.  Educating each patient and family about the disease and treatments are what I consider to be the most critical part of my job.  Part of that education is emphasizing not only the pros and cons and goals of each treatment, but also the importance of participating in the process of paving the path for the future for others afflicted with the disease.