For certain types and cases of cancer, less treatment could be more beneficial. This is an idea that interests many physicians, as new tests and therapies are prolonging patients’ lives and moving cancer treatment away from harsh, one-time approaches such as radiation therapy.
Recently, at the annual conference of the American Society of Clinical Oncology (ASCO) in Chicago, Partnering With Patients: The Cornerstone of Cancer Care and Research, several studies were presented that expand the body of evidence being used by healthcare professionals to design treatment plans reducing the side effects and costs of cancer treatment.
These studies have shown, for example, that patients with pancreatic and cervical cancer can obtain equally positive outcomes with less invasive surgery. Studies were also presented that concluded that patients with rectal cancer or Hodgkin’s lymphoma can safely receive less radiation.
Partnering With Patients: The Cornerstone of Cancer Care and Research.
“It’s time to consider less toxic approaches,” said Dr. Julie Gralow, chief medical officer and executive vice president of ASCO, as reported in The Wall Street Journal.
Invasive cancer treatments, such as radiation therapy, are known to have various possible side effects:
- Changes in skin color and texture
- Irritation or burns on the treated area
- Temporary hair loss in the irradiated area
- Gastrointestinal problems (such as nausea, diarrhea or vomiting)
- Urinary problems
- Dryness or irritation in the mouth and throat
These effects vary according to the type of treatment, the location and stage of the cancer, and the patient’s individual characteristics.
Impact of Less Invasive Treatments
Studies seeking alternatives to intensive or invasive treatments, without harming patient survival, are not new, although they have grown significantly in recent years.
For example, a paper published in February 2023 in The New England Journal of Medicine found that more older women with low-risk breast cancer could skip radiation therapy after surgery, thus avoiding side effects and higher costs.
In that study, 1,326 patients aged 65 years or older with early-stage breast cancer underwent surgery and hormone therapy. They were then divided into one group that received radiation (658) and another group that did not (668).
Ten years after surgery, survival rates in the two groups were practically equal, suggesting that more women could skip radiation therapy without affecting their survival.
Several studies along similar lines were presented at the ASCO annual conference. For example, one study found that a modified radical hysterectomy, which removes only the uterus and cervix, may be safe for some patients with low-risk cervical cancer, rather than resorting to a radical hysterectomy that can be more complex and costly.
The researchers noted that women who underwent the simpler surgery reported better body image, greater sexual activity, fewer bladder problems, and lower pain levels.
Another paper presented at the conference, which was published in The New England Journal of Medicine, assessed the possibility of receiving more aggressive chemotherapy without radiation, rather than combining standard chemotherapy and radiation, to fight rectal cancer.
The study divided nearly 1,200 patients into two groups. After five years, the results of the two protocols were similar. According to researchers, this suggests that many patients with rectal cancer can safely skip radiation, which raises the risks of pelvic fractures, infertility, sexual dysfunction, and bowel dysfunction.
However, patients who avoided radiation by undergoing more aggressive chemotherapy experienced more short-term side effects, such as loss of appetite, fatigue, and nervous system damage.
“It’s a complicated and nuanced decision, but it makes it possible to customize the choice of treatment to patients’ preferences,” said Dr. Harvey Mamon, as reported by The Wall Street Journal. Mamon, chief of gastrointestinal radiation oncology at Dana-Farber Cancer Institute, was the lead author of the trial.
At the conference, a paper was also presented that showed that patients who underwent laparoscopic or robotic-assisted surgery had similar outcomes to patients who had more invasive open surgery.
Meanwhile, another study showed that patients aged 12 years or older with advanced Hodgkin’s lymphoma who received an immunotherapy drug and chemotherapy had better outcomes after one year compared to the current standard treatment. In addition, the authors stated that fewer than 1% of patients in the trial needed radiation, while the rate is normally around 50% for pediatric patients.
In terms of the implementation of new treatments, the U.S. Food and Drug Administration (FDA) recently issued the draft guidance document “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics,” regarding considerations for designing clinical trials to support accelerated approval applications.
As the FDA explains, the accelerated approval pathway is commonly used for approval of oncology drugs, in part due to the serious and potentially life-threatening nature of cancer, and because of available intermediate clinical endpoints that are likely to predict clinical benefit.
“The FDA’s accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence.
He added: “Today’s draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval. Building quality and efficiency into the design of oncology clinical trials is a crucial component in providing maximum benefit to those living with cancer.”
This story was produced using content from original studies or reports and from other medical research, as well as health and public health sources, highlighted in related links throughout the article.
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