Facing a rectal cancer diagnosis can be overwhelming, especially for older patients. But what if a shorter, less intensive radiation treatment could offer similar results to the standard, longer course?
That's the promise of short-course radiotherapy (SCRT) for older adults with locally advanced rectal cancer (LARC) who can't undergo chemotherapy. A recent study, known as the SOFT study (Protocol number 20240025859) and published in Radiotherapy and Oncology, suggests this could be a viable option.
The SOFT study revealed some promising outcomes. The objective response rate (ORR) was an impressive 61.7% (with a confidence interval of 53.2%-69.8%). This means a significant portion of patients saw their tumors shrink. Furthermore, 7.1% (confidence interval: 3.5%-12.7%) achieved a complete clinical response (CR), meaning no signs of cancer were detectable after treatment. Partial responses (PR), where tumors shrank but didn't disappear, were seen in 54.6% (confidence interval: 46.0%-53.0%) of patients. The disease control rate (DCR) was remarkably high at 96.4% (confidence interval: 91.9%-98.8%).
But that's not all. A pathological complete response (pCR), where no cancer cells were found in the removed tissue, occurred in 5.7% of patients. Also, 56.9% of patients showed downstaging of their disease, indicating the cancer had shrunk or spread less than before treatment. The R0 resection rate, which indicates the cancer was completely removed during surgery, was also high at 93.6%.
Looking at survival, the study showed a median relapse-free survival (RFS) of 31.5 months (confidence interval: 16.0-46.9), a median overall survival (OS) of 40.5 months (confidence interval: 31.0-49.9), and a median cancer-specific survival (CSS) of 41.5 months (confidence interval: 31.3-51.7). During the observation period, 21 patients passed away, with 9.9% of those deaths related to the tumor and 5.0% due to other causes. The OS rates were 78% at 1 year, 50% at 2 years, 30% at 3 years, and 5% at 5 years.
Lead study author Gerardo Rosati, from the Medical Oncology Unit of S. Carlo Hospital in Potenza, Italy, and his coauthors concluded that SCRT appears to be an effective and feasible alternative for older patients, especially those with other health issues who may find long-term treatments challenging. It offers similar oncological outcomes to traditional therapy, with the added benefits of a shorter treatment time and better tolerability. They also emphasized the need for further studies, particularly randomized controlled trials with longer follow-up periods, to fully assess the long-term safety and effectiveness of SCRT in this group. However, SCRT represents a valuable tool in treating older patients with LARC.
Here's where it gets interesting: The study involved 141 older patients with LARC who couldn't receive chemotherapy. They underwent SCRT followed by delayed surgery across 11 Italian treatment centers. The radiotherapy involved a total of 25 Gy spread over 5 daily fractions of 5 Gy each.
The study's primary goals were to assess the safety and effectiveness of SCRT in this patient group. They measured the ORR and downstaging after radiotherapy to determine efficacy, while also tracking the incidence and severity of any side effects to assess safety. Secondary endpoints included pCR rate, R0 resection rate, RFS, CSS, and OS.
To be included in the study, patients needed to have a confirmed diagnosis of adenocarcinoma of the rectum within 12 cm of the anal verge, resectable T3 or T4 disease (without lymph node involvement), and be unsuitable for chemotherapy. They also needed an ECOG performance status of 0 to 2.
The average age of the patients was 79 years, with most being between 70 and 80 years old (54.6%) and male (60.2%). The majority had an ECOG performance status of 1 (50.3%), differentiated disease (80.1%), stage III disease (68.8%), and underwent surgery via low anterior resection (73.7%).
Complications occurred in 23.4% of patients. These included anastomosis dehiscence (8.5%), abdominal infection (5.7%), wound healing problems (3.5%), bleeding (2.8%), and intestinal sub-occlusions (2.8%). Post-surgery deaths occurred in 2.8% of patients, with 3 deaths from sepsis and 1 from hydronephrosis and renal failure.
A Note on the Data: The study's authors point out that, while their findings are promising, the study only included patients who underwent surgery. This may not fully represent all cases.
But here's where it gets controversial... SCRT has emerged as a potential strategy to reduce the burden of prolonged therapy for older patients with LARC. However, it's worth noting that the literature contains conflicting data on this approach.
What do you think? Does this information change your perspective on rectal cancer treatment? Are you surprised by the results, or do they align with your existing knowledge? Share your thoughts and questions in the comments below!
