The right treatments are available if the correct trials are used to show that therapy is improving.

This editorial article published at The Journal of Clinical Oncology, expresses experts' opinion, criticizing the current practice and design of clinical trials involving patients with rectal cancer.

Despite improvements in treatment options, such as the addition of the platinum-based drug Oxaliplatin to chemotherapy regimens, little progress has been made at improving outcomes or reducing the recurrence rates of rectal cancer.  

The author criticizes prominent clinical trials such as the ACCORD and STAR studies. These studies evaluated the addition of Oxaliplatin to a 5-FU-based chemotherapy regimen (given before or after surgery). In the ACCORD study, 3% of patients in the control group compared to 0.5% in the Oxaliplatin treated group developed metastasis after surgery. Similarly, in the STAR study, rates were 4% versus 2.7%. However, about 50-60% of patients included in these studies probably had T2 or T3 cancers that did not spread to lymph nodes. Such patients are considered as “low risk” and expected to have good prognosis regardless of  treatment.

The author claims that study participants could be stratified into risk groups, according to their risk of developing cancer recurrence. To do this, common diagnostic methods could be implemented into clinical practice, or tested in trials, to identify high risk patients who will benefit from post-operative complementary treatments (radiation and chemotherapy). For example, ultrasound can be used to identify tumors that are stage T2 or less (tumors not invading beyond the muscular layer of the rectal wall), magnetic resonance imaging (MRI) can determine how far beyond the muscle wall the tumor has invaded. Both methods have a high resolution and sensitivity to detect small changes in tumor size and rectal wall invasion. The author suggests that patients whose tumors have invaded more than 5mm of rectal wall thickness (as shown by MRI) may be classified as high risk, along with those who have positive lymph nodes.  

It is the authors' overall opinion that if patients were stratified in studies as well as clinical practice into risk groups, treatment choices may be more individualized and suitable, thereby outcomes may improve and drugs could be more accurately assessed in trials.

It is important for readers to recognise that this is a letter. It discusses the authors opinions rather than results of an individual clinical study.