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Some Older Women With Early-Stage Hormone-Receptor-Positive, Node-Positive Breast Cancer Can Skip Chemotherapy

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Postmenopausal women diagnosed with early-stage hormone-receptor-positive, HER2-negative breast cancer with one to three positive lymph nodes can safely skip chemotherapy if they have an Oncotype DX Recurrence Score of 25 or lower, according to the RxPonder study.

The research was presented on Dec. 10, 2020, at the 2020 San Antonio Breast Cancer Symposium. Read the abstract of “First results from a phase III randomized clinical trial of standard adjuvant endocrine therapy (ET) +/- chemotherapy (CT) in patients (pts) with 1-3 positive nodes, hormone-receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) ≤ 25: SWOG S1007 (RxPonder).”

About the Oncotype DX test
About the RxPonder study
What this means for you

About the Oncotype DX test

The Oncotype DX test is a genomic test that analyzes the activity of a group of 21 genes from a breast cancer tissue sample that can affect how a cancer is likely to behave and respond to treatment.

Currently, doctors use the Oncotype DX test to help figure out a woman’s risk of early-stage estrogen-receptor-positive, HER2-negative, node-negative breast cancer coming back (recurrence), as well as how likely she is to benefit from chemotherapy after breast cancer surgery.

The Oncotype DX test results assign a Recurrence Score — a number between 0 and 100 — to the early-stage breast cancer. Based on your age, you and your doctor can use the following ranges to interpret your results for early-stage invasive breast cancer.

For women older than 50 years of age:

  • Recurrence Score of 0-25: The cancer has a low risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 26-100: The cancer has a high risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.

For women age 50 and younger:

  • Recurrence Score of 0-15: The cancer has a low risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 16-20: The cancer has a low to medium risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 21-25: The cancer has a medium risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.
  • Recurrence Score of 26-100: The cancer has a high risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.

In the study reviewed here, called the RxPonder trial, the researchers wanted to know if the Oncotype DX Recurrence Score could also be used to help make decisions about early-stage hormone-receptor-positive, HER2-negative breast cancer that has spread to one to three lymph nodes.

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About the RxPonder study

The study included 5,083 women diagnosed with stage II to stage III hormone-receptor-positive, HER2-negative breast cancer that had spread to one to three lymph nodes. All the women had an Oncotype DX Recurrence Score of 25 or lower.

After surgery to remove the cancer, the women were randomly assigned to one of two treatments:

  • hormonal therapy alone
  • hormonal therapy plus taxane and/or anthracycline chemotherapy

Taxane chemotherapy medicines include:

  • Taxol (chemical name: paclitaxel)
  • Abraxane (chemical name: nab-paclitaxel)
  • Taxotere (chemical name: docetaxel)

Anthracycline chemotherapy medicines include:

  • Adriamycin (chemical name: doxorubicin)
  • Doxil (chemical name: liposomal doxorubicin)
  • daunorubicin (brand names: Cerubidine, DaunoXome)
  • Ellence (chemical name: epirubicin)
  • mitoxantrone (brand name: Novantrone)

About 66% of the women were postmenopausal.

Half the women were followed for more than 5 years and half were followed for shorter periods of time.

Information from 5,015 women was analyzed for this study.

The researchers measured how long the women lived without the cancer coming back, called disease-free survival.

The researchers were surprised to see that overall, there was no association between Recurrence Score and chemotherapy benefits. This means that women with a higher Recurrence Score didn’t get more benefits from chemotherapy than women with a lower Recurrence Score.

When the researchers looked at the results by the women’s menopausal status, they found that postmenopausal women got no benefits from chemotherapy, no matter their Recurrence Score. In other words, there was no difference in 5-year disease-free survival between postmenopausal women treated with chemotherapy and hormonal therapy and postmenopausal women treated with hormonal therapy alone.

“Postmenopausal women with one to three positive nodes and a recurrence score of 0 to 25 can likely safely forgo adjuvant chemotherapy without compromising invasive disease-free survival,” said presenting author Kevin Kalinsky, M.D., director of the Glenn Family Breast Center at Winship Cancer Institute of Emory University, during a media briefing on the study. “This will save tens of thousands of women the time, expense, and potentially harmful side effects that can be associated with chemotherapy infusions.”

In contrast, the researchers found completely different results when they looked at premenopausal women.

In this group, 5-year disease-free survival rates were:

  • 94.2% for women treated with chemotherapy and hormonal therapy
  • 89.0% for women treated with hormonal therapy alone

This difference was statistically significant, which means that it was likely due to the difference in treatment and not just because of chance.

The difference in disease-free survival was seen for all Recurrence Scores.

“For premenopausal patients with node-positive breast cancer, we know from other studies that the most effective adjuvant endocrine therapy is ovarian suppression combined with an aromatase inhibitor. We also know that chemotherapy induces ovarian suppression that is often permanent in premenopausal women,” explained Kalinsky.

Among the premenopausal women in the study, 15.9% of women in the hormonal therapy-alone group were treated with ovarian suppression, compared to 3.7% of women in the chemotherapy plus hormonal therapy group.

“To what extent the chemotherapy benefit observed in our trial is due to chemotherapy-induced menopause remains unknown,” Kalinsky noted.

Still, at the media briefing, the two moderators were skeptical about chemotherapy working differently in pre- and postmenopausal women and suggested that the difference could be due to ovarian suppression in the premenopausal women.

“Until we show that it's not an endocrine effect, I'm pretty skeptical,” said co-moderator C. Kent Osborne, M.D., of the Baylor College of Medicine. “I just can't imagine why that group of patients would have a different response to chemotherapy. If I could think of a rationale and believe in it, I would. I would hate to come away with the message that premenopausal patients should get chemotherapy.”

“I honestly think that is an ovarian suppression effect that we are seeing,” added co-moderator Virginia Kaklamani, M.D., of UT Health San Antonio. “We have several clinical trials that have been done looking at ovarian function suppression versus not, and even some trials that were done back in the late ‘90s showed that ovarian function suppression can help as much as chemotherapy. Unfortunately, the arms in those trials were not perfect. For now, this is going to be an unanswered question, but I really believe this is an ovarian function suppression effect.”

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What this means for you

If you’re a postmenopausal woman diagnosed with early-stage hormone-receptor-positive, HER2-negative breast cancer that has spread to one to three lymph nodes and you have an Oncotype DX Recurrence Score of 25 or lower, the results from the RxPonder study offer some good news. The results strongly suggest that you can safely skip chemotherapy after surgery — hormonal therapy alone offers the same disease-free survival.

“This study represents an important step toward the goal of matching patients with the most appropriate therapies and ensuring that patients do not receive treatments that are unlikely to benefit them,” Larissa Korde, M.D., head of Breast Cancer and Melanoma Therapeutics in the National Cancer Institute’s Cancer Therapy Evaluation Program, said in a statement. “These findings and additional results from this clinical trial can be expected to help improve the care of many women with a common form of breast cancer.”

If you are a premenopausal woman, results from the RxPonder trial are less clear. You and your doctor may consider using another genomic test, such as the EndoPredict test or the MammaPrint test, to help figure out if you would benefit from both hormonal therapy and chemotherapy after breast cancer surgery.

Besides any genomic test results, you and your doctor will consider other factors when developing your treatment plan, such as:

  • your age
  • the size of the cancer
  • hormone receptor protein levels
  • the grade of the cancer
  • any other health conditions you have
  • your family history of cancer
  • your personal preferences

Together, you can make the best treatment decisions for your unique situation.

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Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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