The theme of the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting is Partnering With Patients: The Cornerstone of Cancer Care and Research. From June 2 to 6 in Chicago, Illinois, and online, cancer researchers and clinicians from around the world will gather to discuss the latest research and how to ensure that all people receive the cancer care they need.
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Some of the notable research that will be presented today includes:
Simple hysterectomy is a safe, effective treatment option for early-stage cervical cancer
Who does this study affect: People with low-risk, early-stage cervical cancer.
What did this study find: The phase 3 SHAPE clinical trial found that a simple hysterectomy, which is the removal of the uterus and cervix, with pelvic node dissection, which is the removal of the lymph nodes, is a safe, effective treatment option for people with low-risk, early-stage cervical cancer and may help improve quality of life.
Worldwide, cervical cancer is the fourth most commonly diagnosed cancer and fourth most common cause of cancer death in women. About 44% of people with cervical cancer in the United States are diagnosed with early-stage disease. For patients who do not wish to preserve their fertility, which is the ability to become pregnant, the current standard of care for low-risk, early-stage cervical cancer is pelvic node dissection and radical hysterectomy. A radical hysterectomy is the removal of the uterus, cervix, upper vagina, and the tissue around the cervix. Low-risk disease means the cancer has a lower chance of coming back after treatment.
Because a radical hysterectomy is a more complex surgery than a simple hysterectomy, it requires more extensive surgical training and may cause more short-term and long-term side effects, such as bleeding, bladder injury, and bladder and bowel problems. It may also have greater impacts on quality of life and sexual health. In this study, researchers wanted to learn whether the less invasive simple hysterectomy to treat people with early-stage cervical cancer could be used without impacting their risk of recurrence, which is the chance of the cancer coming back.
The SHAPE study included 700 people ages 24 to 80 with low-risk, early-stage cervical cancer, defined as stage 1A2 or 1B1 disease. Participants came from 12 countries and were randomly assigned to receive pelvic node dissection with either radical hysterectomy or simple hysterectomy. Half of the hysterectomies were done laparoscopically, which is surgery using smaller cuts (56% in the simple hysterectomy group vs. 44% in the radical hysterectomy group), 25% robotically (24% in the simple hysterectomy group vs. 25% in the radical hysterectomy group), and 23% using open abdomen surgery with a single large cut (17% in the simple hysterectomy group vs. 29% in the radical hysterectomy group).
In this study, the researchers looked at the participants’ pelvic recurrence rate, which is the percentage of people who experienced a recurrence in the pelvic area, 3 years after surgery. They found that the pelvic recurrence rate of those receiving the simple hysterectomy was nearly the same as the radical hysterectomy. In the simple hysterectomy group, 2.5% of participants experienced a pelvic recurrence compared with 2.2% of those in the radical hysterectomy group. Overall, after a median follow-up of 4.5 years, there were 11 pelvic recurrences in the simple hysterectomy group and 10 in the radical hysterectomy group. The median is the midpoint, meaning half of the participants were watched for less than 4.5 years and half were watched longer. The surgical approach used for the procedure did not seem to influence the risk of recurrence in either group.
Survival rates were also similar between the 2 groups after 3 years. The extrapelvic relapse-free survival rate, or the percentage of people who did not experience a recurrence elsewhere in the body, was 98.1% in the simple hysterectomy group vs. 99.7% in the radical hysterectomy group. The overall survival rate, or percentage of people who were still alive, was 99.1% in the simple hysterectomy group vs. 99.4% in the radical hysterectomy group.
Finally, people in the simple hysterectomy group experienced fewer complications during surgery and had fewer immediate and long-term bladder problems. Several quality-of-life aspects, such as body image, pain, and sexual health, were also better in the simple hysterectomy group.
What does this mean for patients? Simple hysterectomy with pelvic node dissection may be a safe, effective treatment option for people with low-risk, early-stage cervical cancer and may help improve quality of life. These findings may also be useful in low-income and middle-income countries, where people may have less access to complex surgery like radical hysterectomy.
“These results are important because it demonstrates, for the first time, that a simple hysterectomy is a safe option for women with carefully selected early-stage low-risk cervical cancer. This trial will likely be practice-changing, with the new standard-of-care treatment for patients with low-risk disease being a simple hysterectomy instead of radical hysterectomy.”
— lead study author Marie Plante, MD
Laval University
Quebec, Canada
Adding ribociclib to hormonal therapy may reduce risk of recurrence for some people with early-stage breast cancer
Who does this study affect: People diagnosed with hormone-receptor positive (HR-positive), HER2-negative early-stage breast cancer.
What did this study find: The phase 3 NATALEE clinical trial found that adding the targeted therapy drug ribociclib (Kisqali) to hormonal therapy for the adjuvant treatment of people diagnosed with HR-positive, HER2-negative early-stage breast cancer helped reduce the risk of the cancer coming back, called a recurrence. Adjuvant treatment is given after the main treatment is completed.
HR-positive, HER2-negative breast cancer is the most common subtype of breast cancer in the United States, making up nearly 70% of all cases. The main treatment is surgery to remove the tumor. The standard adjuvant treatment for people with this diagnosis is hormonal therapy, also called endocrine therapy. However, after receiving adjuvant hormonal therapy, recurrences happen in about one-third of people with stage II disease and in more than half of people with stage III disease. If the cancer comes back, it is often at a more advanced stage.
Ribociclib is a type of targeted therapy called a small molecule inhibitor that works by targeting a protein in cancer cells called CDK4/6, which may stimulate cancer cell growth. Ribociclib is currently approved by the U.S. Food and Drug Administration to treat HR-positive, HER2-negative advanced or metastatic breast cancer in combination with hormonal therapy. Ribociclib has been shown to help people with advanced breast cancer live longer. In this study, the researchers wanted to learn whether it could also improve outcomes for people with earlier-stage disease.
This study included men and premenopausal or postmenopausal women from 20 countries after surgery for stage IIA, IIB, or III HR-positive, HER2-negative breast cancer at risk for recurrence. Participants were randomly assigned to receive either adjuvant ribociclib for 3 years plus hormonal therapy for at least 5 years (2,549 patients) or hormonal therapy alone for at least 5 years (2,552 patients). Also in this study, researchers wanted to see whether giving ribociclib at a lower dose could help reduce side effects while maintaining the effectiveness of the drug.
At a median follow-up of 34 months, 20.2% of participants in the ribociclib group had completed 3 years of treatment and 56.8% had completed 2 years of treatment. The median is the midpoint, meaning half of the participants were followed up with before 34 months and half were followed up with after. Overall, about 75% of participants were still receiving their assigned treatment at the study’s cutoff for data collection, with 1,984 patients receiving ribociclib plus hormonal therapy and 1,826 patients receiving hormonal therapy alone.
The study found that adding ribociclib to hormonal therapy lowered the risk of recurrence compared with hormonal therapy alone. There were 189 recurrences in the ribociclib group (7.4% of patients) and 237 in the hormonal therapy alone group (9.2% of patients). For those who received 3 years of treatment, 90.4% of those in the ribociclib group did not experience a recurrence compared with 87.1% of those in the hormonal therapy alone group. Overall, the addition of ribociclib reduced the risk of recurrence by 25%, regardless of the stage of disease, whether the cancer had spread to the lymph nodes, and whether the person had been through menopause.
For patients receiving ribociclib, the most common side effects were joint pain and low white blood cell count, called neutropenia. Neutropenia is a known side effect of ribociclib, and it occurred at lower rates than usual for participants in this study, which the researchers expect is likely due to the lower dose given. For patients receiving hormonal therapy alone, the most common side effects were joint pain and hot flashes.
What does this mean for patients? For people diagnosed with HR-positive, HER2-negative early-stage breast cancer, the addition of adjuvant ribociclib to hormonal therapy may help reduce the risk of recurrence and, when given at a lower dose, may help reduce side effects without impacting the effectiveness of the drug.
“Currently approved targeted treatments can only be used in a small population of patients diagnosed with HR-positive, HER2-negative early breast cancer, leaving many without an effective treatment option for reducing risk of the cancer returning. Thus, there is a significant unmet need for both reducing the risk of recurrence and providing a tolerable treatment option that keeps patients cancer-free without disrupting their daily life. The NATALEE study investigated the addition of ribociclib to standard-of-care adjuvant endocrine therapy and was specifically designed to address these unmet needs.”
—lead study author Dennis J. Slamon, MD, PhD
University of California, Los Angeles (UCLA)
Los Angeles, California
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