Jason Harris

A combination of Ibrance (palbociclib) and Faslodex (fulvestrant) improved overall survival (the time from diagnosis or treatment when a patient is still alive) compared with placebo plus Faslodex in patients with HR-positive, HER2-negative advanced breast cancer.

Dr. Massimo Cristofanilli, associate director for translational research at the Lurie Cancer Center and a professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine, presented the findings during the 2021 ASCO Annual Meeting.

“An improvement in (overall survival) with Ibrance plus (Faslodex) continues to be observed with more than six years of median follow up in patients with HR-positive advanced breast cancer who progressed on prior endocrine therapy,” Cristofanilli said. “This prolonged (overall survival) benefit is particularly evident in patients with endocrine-sensitive disease and those with prior exposure to chemotherapy in the advanced setting.”

Investigators in the phase 3 trial randomly assigned 521 patients with metastatic breast cancer whose disease progressed on or following endocrine treatment to Faslodex plus Ibrance (347 patients; median age, 57 years) or Faslodex plus placebo (174 patients; median age, 56 years).

The updated median overall survival for patients who received Ibrance plus Faslodex was 34.8 months versus 28 months in the placebo group. After a median follow-up of 44.8 months, the median overall survival was 34.9 months for those who received Ibrance plus Faslodex compared with 28 months for the placebo group.

“Remarkable in this metastatic setting is that the five-year (overall survival) rate is 23.3% in the (Ibrance group) compared with 16.8% in the placebo (group),” he added.

Cristofanilli noted that 34% of patients had received prior chemotherapy for advanced breast cancer and 35% received more than two lines of prior treatment. He said that these types of patients had been excluded from other phase 3 studies testing CDK4/6 inhibitors like Ibrance with Faslodex.

In patients who had not received prior chemotherapy for advanced disease, those who received Ibrance plus Faslodex had a median overall survival of 39.3 months, while the placebo group reported 29.7 months. In contrast, there was no survival benefit for the combination in patients who did receive chemotherapy previously.

Ibrance conferred an overall survival benefit regardless of ESR1 or PIK3CA mutation status, Cristofanilli said. Mutation status may predict overall survival benefit and was highly associated with shorter overall survival in patients with ESR1 mutation. PIK3CA mutations were also associated with shorter overall survival but the connection was weak.

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The survival benefit obtained with Ibrance plus Faslodex persisted over a median follow-up of 73.3 months in patients with HR-positive, HER2-negative advanced breast cancer.

Ibrance Plus Faslodex May Improve Long-Term Survival for Advanced Breast Cancer

Patients with advanced gastrointestinal stromal tumor (GIST) who received a dose escalation of Qinlock (ripretinib) following disease progression after treatment with fourth-line therapy achieved extended survival outcomes, according to an analysis of phase 3 findings.

“Based on this exploratory analysis of the phase 3 INVICTUS study, (Qinlock) dose escalated to 150 (milligrams twice a day) after disease progression on (Qinlock 150 milligrams once a day) provided clinical benefits for patients with advanced GIST receiving more than fourth line therapy,” lead study author Dr. John R. Zalcberg, head of cancer research at Monash University in Melbourne, Australia, said during a presentation of the data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Zalcberg added that the findings provide another treatment option for patients who have received Qinlock in the fourth-line setting.

In the INVICTUS study, investigators enrolled 129 patients previously treated with three or more prior tyrosine kinase inhibitors (TKIs), including Gleevec (imatinib), Sutent (sunitinib) or Stivarga (regorafenib). Patients were randomly assigned to receive either Qinlock at a starting dose of 150 milligrams (mg) once daily (85 patients) or placebo (44 patients) in the fourth-line setting and received treatment until progressive disease.

In this analysis (data cutoff of August 10, 2020), 43 patients in the dose-escalation group received study drug at 150 mg once a day and were then escalated to 150 mg twice a day. Among these patients, the median progression-free survival (time during and after treatment when the patient lives without disease progression) was 4.6 months during the once-a-day treatment period. After dose-escalation, the median progression-free survival increased another 3.7 months.

The median duration of treatment in the group who received 150 mg of Qinlock twice a day was 3.7 months. Between the once-a-day and twice-a-day periods, 37.2% of patients were on treatment for 12 months or more.

The median overall survival (time that a patient with cancer is still alive) was 18.4 months in the group who received Qinlock twice a day compared with 14.2 months for those who did not proceed to dose escalation. Of note, the median overall survival among the 85 patients who received study drug was 18.2 months compared with 6.3 months for those assigned to placebo.

Zalcberg noted that patients tolerated the dose escalation well. The only new or worsening serious or severe treatment-related side effects were anemia in six patients and abdominal pain in three patients.

In May 2020, the Food and Drug Administration (FDA) 

approved Qinlock for the fourth-line treatment of patients with GIST

 based on findings from the phase 3 INVICTUS trial.

“Today's approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST,” Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, said in a news release at the time of the approval.

Twice-daily treatment with Qinlock following disease progression after treatment with fourth-line therapy in patients with advanced gastrointestinal stromal tumor was associated with extended survival outcomes.

Higher Dose of Qinlock Improves Survival in Patients with Heavily Pretreated Advanced GIST

Obese patients being treated for breast or prostate cancer showed higher levels of mental and physical distress than nonobese patients, according to results from a retrospective study of more than 4,000 patients age 55 and older.

Investigators did not find the same correlation between obesity and distress in patients with colorectal cancer (CRC). Instead, those patients experienced “significant symptoms and distress” regardless of weight.

Lead study author Errol J. Philip, of the University of California, San Francisco, said the results do not suggest that obesity causes distress in patients with cancer. However, the findings showed a consistent association between excess weight and poorer psychosocial outcomes.

“In patients with breast cancer, obesity was associated with problems around sleep, fatigue, pain and physical functioning such as walking or climbing stairs,” he said in an interview. “We saw a similar pattern among the prostate cancer patients. They also reported high levels of fatigue as well as issues around sexual functioning.

“We can't make any causational arguments at this point, but we're able to identify a number of associations aligned with the broader literature that provide us with better insight into the experiences of patients as they move through treatment with and without excess weight.”

Results from previous studies in the general population have found an association between increasing body mass index (BMI) and greater pain, fatigue and sleep disorders. Furthermore, some reports have found that obese people are at higher risk for certain psychiatric illnesses, especially depression. Philip and his colleagues sought to determine if these observations held true in patients with cancer as well.

Investigators analyzed data from 4,159 patients who were treated at a large comprehensive cancer center in California from 2009 to 2017. Patients eligible for this study were 55 years or older and diagnosed with postmenopausal breast (52.2%), prostate (38.7%) or colon (9.1%) cancer.

Those with a body mass index (BMI) of 30 kg/m

 or more were classified as obese. Mean BMI was highest among patients with prostate cancer (28.6 kg/m

) compared with patients who had breast (28.1 kg/m

) cancer. However, more patients with breast disease (57.9%) were considered obese compared with those with prostate (53.9%) or colon (52.7%) cancer.

As a routine part of care, patients answered questions assessing their distress before starting treatment. They were asked to rank the levels to which they had experienced 33 problems on a five&#8208;point scale from one (not a problem) to five (very severe problem). The questions focused on five domains: physical, practical, functional, emotional and other.

Investigators observed higher distress scores in obese versus nonobese patients in breast cancer (4.6 versus 4.0) and prostate cancer (3.13 versus 2.52). Obese patients in both cohorts also reported more physical, practical, functional and emotional problems.

In contrast, nonobese patients with CRC reported higher distress scores than obese patients (4.12 vs 3.56). Moreover, investigators did not observe a significant difference in physical, practical, functional, emotional or other problem scores between obese and nonobese patients.

The CRC cohort was much smaller than the other groups and Philip suggested that it might have been too small to generate an accurate picture of weight-based distress in these patients.

“Both groups (of CRC patients), regardless of weight status, tended to report fairly high levels of distress. It's possible that the nature of the disease and the sorts of side effects and symptoms that they experience washed out any effect of weight that we could have seen,” he added. “Other studies that have examined the same relationships among CRC patients, ones that have larger numbers of individuals involved, did see that sort of pattern between excess weight and greater symptom burden or greater distress.”

Philip noted that it is impossible for investigators in this study to know how much distress obese patients might have been experiencing prior to diagnosis. Obese people routinely face bias and shaming, so it is possible that these results are capturing elevated stress levels among this population in general, rather than something specific to obese patients being treated for cancer.

“We know that within the general populace, with or without cancer, there is a lot of discrimination and stigma surrounding (obesity),” Philip said. “That's definitely an element that plays into it.”

The U.S. Preventive Services Task Force issued nutrition and exercise recommendations for patients and survivors in 2012. These guidelines say that patients should be as active as possible. Furthermore, survivors are at increased risk for secondary cancers and chronic diseases including cardiovascular disease, diabetes and osteoporosis, and exercise is crucial tool for prevention.

Philip added that published reports show excess weight is associated with poorer outcomes for patients with cancer. The “million-dollar question,” he said, is: How does obesity affect patients as they move through treatment and post-treatment when it comes to symptom burden and engaging in health-promoting behavior?

“We're asking patients to move and eat better, but if you're dealing with a lot of side effects or a lot of distress, that can be difficult,” he said. “If they are experiencing greater symptom burden and poorer outcomes, it is incumbent upon (the medical community) to provide greater support and work out ways to promote health and well-being across that treatment and survivorship period.”

Obese patients being treated for breast or prostate cancer showed higher levels of mental and physical distress than nonobese patients with these diseases, but the pattern did not hold true in those with colorectal cancer, according to a study.
 

Obesity Linked With Higher Distress in Breast and Prostate Cancers

In May, the Pink Luminous Advocacy Project introduced the Breast Awareness app, the first multilingual, unisex breast self-examination application. Although the nonprofit Pink Luminous organization is tasked with supporting breast health in underprivileged communities, CEO Marilyn Dans maintains that the app is meant to encourage self-examinations across the population.

“In all the places we’ve gone and the women we’ve talked to, women feel uncomfortable with breast self-examination, so the app makes it easier,” she said in an interview with 

’s. “[The app] is trying make self-examination really simple, trying to educate and empower individuals to live an awareness lifestyle, to embrace the awareness lifestyle, to make it part of their routine.”

According to an analysis of the Surveillance, Epidemiology, and End Results database, the incidence of breast cancer with distant involvement at diagnosis increased by 2.07% annually in women aged 25 to 39 years from 1976 to 2009. Over the study period, the increased incidence was particularly acute among black (annual percentage change, 3.50%) and Latino women (annual percentage change, 2.67%).

Dans said that an increase in diagnoses among younger women, whose mammograms often are not covered by insurance, inspired Pink Luminous to develop an app to assist these women in particular and, more generally, anyone at risk for breast cancer. The idea was to create something to walk these men and women through a self-exam.

The Pink Luminous Advocacy Project supports and promotes breast cancer awareness in places where education and, specifically, medical education are limited. The organization’s ultimate goal is to “save lives at a global scale by offering educational tools focused on increasing breast health awareness.”

The app presents instructions for self-examination, similar to recommendations from the American Cancer Society, in both text and voice-over formats. It is currently available in English and Spanish and will download in the language set on the user’s device. Dans said a forthcoming update will include more languages.

Early detection is key to successful breast cancer treatment, and regular self-examination can help detect the disease early. The Breast Awareness app serves to educate users and help them become more familiar with their bodies. Dans says it gives individuals the tools to perform routine breast health examinations at home while teaching them how to detect possible abnormalities that require immediate action.

The app, available for Apple and Android, could benefit black and Latino women, who are often diagnosed with advanced disease and are more likely to die from breast cancer compared with white women, and women who face cultural barriers to screening. In a meta-analysis of 39 studies encompassing more than 5.8 million patients, black and Latino populations had lower odds of undergoing screening mammography compared with the white population.

Lead author Dr. Ahmed T. Ahmed said in an interview with 

 that early detection can reduce the risk for disease-specific death by 20%. He added that factors including socioeconomic status, insurance coverage, location, culture, language barriers and religion play a role in screening rates.

Muslim women, for example, are not routinely screened and treated for breast cancer because breast exams and mammograms are not widely accepted in that community, Ahmed said.

“The purpose is to be aware of what your normal breasts feel and look like, to detect any changes, and then to bring up those changes with your doctor,” said Dr. Giselle B. Ghurani, a gynecologist/oncologist with Mercy Hospital in Miami, Florida, and a member of the Pink Luminous advisory board. “The next step would be to raise concerns with a physician, usually a gynecologist.

The app also allows users to create a philanthropic channel and raise money for the Pink Luminous Advocacy Project. Those funds go to supporting the distribution of Pink Luminous Breast devices to women in need, the donation of sonogram machines to breast cancer clinics and the construction of health facilities in developing countries.

“I treat both healthy women and women who are at increased risk for breast and ovarian cancers, as well as women with (gynecologic) cancers. Early detection and disease prevention have always been a big passion of mine because I see how devastating the cancer diagnosis and treatment can be for the patient, the family, and the whole community.”

The Pink Luminous Advocacy Project has introduced the Breast Awareness app, the first multilingual, unisex breast self-examination application.

Jason Harris

Ibrance Plus Faslodex May Improve Long-Term Survival for Advanced Breast Cancer

Higher Dose of Qinlock Improves Survival in Patients with Heavily Pretreated Advanced GIST

Obesity Linked With Higher Distress in Breast and Prostate Cancers

First Multilingual App for Breast Exam Aims to Improve Early Detection

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