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Authors

Dr. David A. Braun is an Assistant Professor of Medicine (Medical Oncology) and a Louis Goodman and Alfred Gilman Yale Scholar, at Yale School of Medicine, and a member of the Center of Molecular and Cellular Oncology at Yale Cancer Center, New Haven, Connecticut.

Dr. David A Braun delved into detail on the molecular factors driving exceptional responses to immunotherapy in metastatic clear cell renal cell carcinoma.

An Expert Expands on What Drives ‘Exceptional’ Responses to RCC Treatment

In a retrospective study of patients with gastrointestinal stromal tumors (GISTs), the utility of both laparoscopic wedge resection (LR) and endoscopic resection (ER) — two minimally invasive approaches to this disease — served as safe and feasible treatment approaches, despite there being disagreement as to which is the better choice among clinicians. However, according to a study published in 

The World Journal of Gastrointestinal Surgery

, LR is specifically recommended for tumors larger than 4 centimeters (cm) compared with ER.

When conducting the retrospective study, the ER group (59 patients) was found to have had longer operative times than the LR group (59 patients) at 120 versus 70 minutes; however, the median postoperative time to liquid diet was significantly shorter in the ER group compared with the LR group (4 days versus 5 days), respectively. Furthermore, the ER group, compared with the LR group, had fewer postoperative symptoms, though there was no significant difference in the postoperative hospital stay (both at 7 days) or hospital costs between the groups.

“Both ER and LR are safe and effective treatments for gastric GISTs [gGISTs]. ER is associated with less postoperative pain and faster recovery and is particularly suitable for cases where cosmetic results or preservation of organ function are desired. In contrast, LR is strongly recommended for large tumors [more than 4 cm] due to its high rate of complete resection,” the study authors wrote in their research.

The Safety of Both Treatment Approaches and Long-Term Outcomes

Regarding safety, there were no significant difference in surgery-related complications between the two groups, though, in the ER group, bleeding occurred in three patients and was treated with conservative treatment or endoscopic hemostasis. In the LR group, postoperative anastomotic fistula occurred in one patient but improved after fasting, adequate drainage, and anti-infection. Five cases of postoperative infection were reported in the ER group versus 8 in the LR group; there was no significant difference in the incidence of postoperative infections between the LR and ER groups.

In all tumors in both groups en bloc resection was achieved, and, in the ER group, 43 tumors received en bloc removal from the stomach and complete resection after PS matching; the remaining 16 tumors were temporarily attached to the stomach using clips though they were then removed en bloc with an endoscopic lithotripter on the next day. Looking to the LR group, 1 tumor did not achieve complete resection because of fragmentation, making the rates of complete resection higher in the LR group versus the ER group. Regarding mitotic count or pathological report risk, there were no significant differences between the groups.

When referring to long-term outcomes, the median follow-up times in the LR and ER groups were 54 months and 51.1 months, respectively; the difference was not statistically significant. In the ER group, GIST recurrence occurred in three patients prior to last follow-up and this number of patients was two in the LR group; again, the difference was not statistically significant. However, following PS matching, no GIST recurrence occurred in the ER group versus two in the LR group, still with no significant difference between the two groups. During the follow-up period, no metastases were observed and no significant difference in mortality between the two patient groups before or after matching was noted. In total, nine patients died across both groups, one of which was due to GIST recurrence and the other eight from other GIST-resection-unrelated diseases.

“The matched ER group showed significantly better outcomes than the LR group in terms of the resumption of a liquid diet and postoperative symptoms. The LR group had an advantage over the ER group in terms of the complete resection rate,” the study authors concluded. “There were no statistically significant differences between the two groups in terms of either the incidence of complications or the long-term postoperative outcomes.”

Diving into the Importance of ER and LR Approaches

GISTs are the most common mesenchymal tumors of the gastrointestinal tract with an annual incidence of 10 to 20 cases per million and primarily occur in the stomach. Management strategies for patients with primary gGISTs depend on tumor size and risk factors; however, surgical excision is recommended for localized gGISTs 2 cm or larger, while active surveillance is advised for smaller, low-risk lesions. There have also been advancements made in minimally invasive approaches to this disease, with techniques such as LR and ER offering benefits like faster recovery and less blood loss.

Despite these advancements, the choice between ER and LR remains a debated topic for gGISTs between 2 to 5 cm in size due to inconsistent outcomes. Some studies suggest LR has lower complication rates and shorter hospital stays while others highlight the advantages of ER, including shorter operation times and reduced costs. Therefore, Taizhou Hospital in the Zhejiang Province has conducted research which aims to provide updated guidance on treatment standardization for gGISTs garnering data.

Investigators reviewed and compiled information on patients with gGISTs who underwent ER or LR at the Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, for their retrospective study from Jan. 2014 to Aug. 2022. Patients were included in this review if they were 18 years of age or older; had a longest tumor diameter of 2 to 5 cm; a diagnosis of gGISTs confirmed by postoperative pathological evaluation and immunohistochemical findings; surgery; and a surgical method of ER or LR. Participants were excluded from the investigation if they did not complete surgery; had adjacent organ invasion; or duodenal and small intestinal stromal tumors.

Furthermore, all patients underwent regular postoperative follow-up by endoscopic examination and CT. Additional follow-up data were acquired via telephone interviews or outpatient follow-up after surgery. Notably, follow-up time was defined as the period from the date of surgery to the last follow-up (August 2023) or death.

Prior to PS matching, in the ER group, the tumor size was significantly smaller (3.5 cm) compared with the LR group (4.2 cm), and the distribution of tumor locations differed between the groups. Notably, 63.4% of patients had tumors located in the gastric body in the LR group, as well as 0% in the gastric cardia, 28.2% in the gastric body and 8.4% in the gastric antrum. In the ER group, 48.9%, 3.7%, 42.2% and 5.2% of the tumors were located in the gastric body, cardia, fundus and antrum, respectively.

However, the study authors wrote that, “We performed a PS-matched analysis to eliminate the impact of confounding factors and enhance the credibility of the findings. After PS matching, 59 patients from each group were selected and included in the subsequent analysis. Post-matching, there were no significant differences between the two groups in terms of these factors.”

“Comparison of endoscopic and laparoscopic resection of gastric gastrointestinal stromal tumors: A propensity score-matched study.” Gu BB, et al. 

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Laparoscopic wedge resection (LR) and endoscopic resection (ER) are both viable minimally invasive treatments for gastrointestinal stromal tumors (GISTs), with LR recommended for tumors larger than 4 cm. A retrospective study found ER associated with longer operative times but faster recovery and fewer postoperative symptoms compared to LR. Both methods showed similar safety profiles and long-term outcomes, with no significant differences in complications or recurrence rates. The study emphasizes the importance of tumor size and location in choosing between ER and LR for optimal treatment outcomes.

Both laparoscopic wedge and endoscopic resection are safe and feasible treatment approaches for patients with gastric gastrointestinal stromal tumors.

Tumor

Laparoscopic Wedge and Endoscopic Resection Are Safe, Feasible in Gastric GISTs 

Interruption of treatment with Gleevec (imatinib) among some patients with advanced gastrointestinal stromal tumors (GIST) has been found by researchers to be associated with a faster occurrence of resistance to Gleevec and an increased risk of disease progression or death.

In the phase 3 BFR14 study, findings of which were published in 

, patients with advanced GIST were divided into two groups: those with stable or responding disease whose treatment was discontinued then restarted at the time of progression in the interruption group or those who received continuation of treatment until progression in the continuation group. Interruption of treatment, researchers noted, was associated with rapid disease progression among patients in the interruption group after one year, three years and five years.

At a median follow-up of 235.2 months after the one-year randomization, 200.9 months after the three-year randomization and 164.5 months after the five-year randomization, the median progression-free survival (the time a patient lives without their disease spreading or worsening) in the interruption and continuation groups was 6.1 months versus 27.8 months after one year of Gleevec, seven months versus 67 months after three years of Gleevec and 12 months versus not reached (meaning fewer than half of the patients in that arm experienced disease progression or died) after five years of Gleevec.

Likewise, the median time until resistance to Gleevec was 28.7 months in the interruption group and 90.6 months in the continuation group after one year on Gleevec, 66.2 months versus 127.3 months after three years and 58.6 months versus not reached after five years, researchers reported.

Additionally, the median overall survival (the time a patient lives, regardless of disease status) was 56 months in the interruption group and 105 months in the continuation group after one year on Gleevec, 104 months versus 134 months after three years and not reached versus 110.4 months after five years, according to the study findings.

At 12 years, 9% of patients in the interruption group were still alive versus 50% of the continuation group after the three-year randomization, compared to 33% and 83% of patients, respectively, after the five-year randomization.

“[Gleevec] interruption in patients with GIST without progressive disease is not recommended,” researchers wrote in the introduction to their findings. “[Gleevec] interruption in non-progressing patients with GIST was associated with rapid progression, faster resistance to [Gleevec] and shorter overall survival in the long-term follow-up when compared with [Gleevec] continuation in patients after three years and five years of [Gleevec].”

These observa­tions have possible relevance for chronic myeloid leukemia and other cancers treated with tyrosine kinase inhibitors, a class of drugs that includes Gleevec, researchers noted

GIST, according to the American Cancer Society, is a group of uncommon cancers that begin in the cells in the wall of the gastrointestinal, or digestive, tract. Approximately 60% of cases of GIST begin in the stomach, and about 35% of cases begin in the small intestine, with most of the rest found in the esophagus, colon and rectum, with a small amount developing in the abdomen, the American Cancer Society explained, noting that approximately 4,000 to 6,000 cases of GIST are diagnosed in the United States each year. GIST, the organization stated, is most commonly diagnosed among people older than 50, but can develop among people of any age.

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Interruption of Gleevec (imatinib) treatment in patients with advanced gastrointestinal stromal tumors (GIST) leads to faster resistance, increased disease progression, and reduced overall survival. The phase 3 BFR14 study demonstrated that continuous treatment significantly prolongs progression-free survival and delays resistance compared to treatment interruption. Median progression-free survival and overall survival were notably longer in the continuation group across one, three, and five-year intervals. These findings suggest that continuous Gleevec therapy is crucial for managing GIST and may have implications for other cancers treated with tyrosine kinase inhibitors.

Researchers are advising against the interruption of treatment with Gleevec among patients with advanced gastrointestinal stromal tumors.

Gleevec Interruption in GIST Associated with Resistance, Recurrence, Death

One of this year’s MPN Heroes® talked about the importance of a supportive care team, especially as every patient with MPN presents differently.

The Power of Voice in MPN Management

Patients with myeloproliferative neoplasms (MPNs) should be actively involved in understanding their disease and communicating specific needs and concerns to healthcare providers, an expert said.

Kathryn Johnson, clinical program manager for the MPN and leukemia programs at the Icahn School of Medicine at Mount Sinai in New York, was honored at the MPN Heroes® in-person ceremony in December 2024 for her work in clinical trials in the space.

Johnson’s nominator noted that throughout the last five years, she has witnessed her dedication to providing care for patients with MPNs, while connecting them to the resources they need and advocating for them with insurance companies.

“Kathryn works with patients undergoing experimental treatments, often a daunting time filled with uncertainty,” her nominator wrote. “Yet, her presence brings an immediate sense of calm and reassurance, helping patients feel that everything will be OK.”

CURE also spoke with Johnson to learn more about how patients can lean into their care teams and trust them so that conversations about symptoms and side effects can be held in an effective manner.

Speak up. Especially with MPNs, you know, they do all manifest differently. There are things that we know that people have in common, but they're going to present differently for every person. And I think that there's a lot that people learn to grow with that they don't always realize is impacting them. So taking a good look at who they are, what their goals are, is going to be helpful to managing their care and making sure that they're vocalizing things that aren't sitting right.

And then also [I] always encourage bring a buddy, bring a sister, bring a parent, bring a spouse, bring an adult child, the people who love you, love you and support you and want to help you manage this that you're going through.

One of this year’s MPN Heroes® talks about the importance of a supportive care team, especially since every patient with MPN presents differently.

Conference

Dr. Eric K. Singhi discusses the significance of the FDA approval of subcutaneous Opdivo for patients with solid tumors.

A Breakdown of Trial Data that Led to the Subcutaneous Opdivo FDA Approval 

Dr. Eric K. Singhi, an assistant professor in both the Department of General Oncology and the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, in Houston, Texas, recently sat down for an interview with CURE®.

In the interview, he discussed the Dec. 27, 2024, Food and Drug Administration (FDA) 

approval of subcutaneous Opdivo and Qvantig

 (nivolumab and hyaluronidase-nvhy) for patients with solid tumors. He goes on to discuss the significance of the regulatory approval, as well as the trial data that led the approval.

As of Dec. 27, 2024, the FDA approved subcutaneous — or under the skin — Opdivo for patients with a wide range of solid tumors. This includes renal cell carcinoma [RCC], melanoma, non-small cell lung cancer and others. The new approval applies to almost all existing solid tumor indications for the IV [intravenous] formulation, except it is not allowed for use in combination with what we call dual immunotherapy or CTLA4 inhibition with Yervoy [ipilimumab].

This approval brings a subcutaneously administered PD1 inhibitor to the market, and it could be significant for patients because it provides a new, more convenient option for treatment. This allows patients to potentially receive treatment closer to home with less time spent at treatment facilities, and it can improve both convenience and accessibility.

, and that included 495 patients with advanced or metastatic clear cell RCC, which is a type of kidney cancer. Importantly, these patients had to have received no more than two prior lines of treatment against their cancer. The trial compared subcutaneous — under the skin — Opdivo with the IV formulation of Opdivo, which is that traditional form of immunotherapy. What they looked at was a primary focus on assessing drug pharmacokinetics. Specifically, they looked at exposure through the time average concentration and minimum concentration at steady state.

What they saw from the results perspective was that the subcutaneous, under-the-skin Opdivo was non-inferior to the IV version, so it indicated comparable levels of drug exposure. What they also saw was that the overall response rate, meaning the percentage of patients that respond to treatment, was actually higher for subcutaneous nivolumab, at 24% compared with 18% for the IV formulation. This really supports the efficacy of the subcutaneous version.

Safety profiles were also the same, or very similar between the two arms. In the subcutaneous, under-the-skin arm, the most common adverse effects were reported in at least 10% of patients, and they included fatigue, musculoskeletal pain, pruritus or intense itching, rash and cough.

Transcript was edited for clarity and conciseness.

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The FDA approved subcutaneous Opdivo (nivolumab and hyaluronidase-nvhy) for solid tumors, excluding dual immunotherapy with Yervoy. This approval, based on the CHECKMATE-67T trial, offers a more convenient treatment option, potentially improving accessibility. The trial demonstrated non-inferiority in drug exposure compared to the IV formulation, with a higher overall response rate for the subcutaneous version (24% vs. 18%). Safety profiles were similar, with common adverse effects including fatigue, musculoskeletal pain, pruritus, rash, and cough, reported in at least 10% of patients.

Dr. Richard “Rick" Winneker discussed advice that he would provide to patients faced with a myeloproliferative neoplasm diagnosis.

Putting an Emphasis on Patient Collaboration in MPN Treatment

Dr. Richard “Rick" Winneker discussed advice that he would provide to patients faced with a myeloproliferative neoplasm (MPN) diagnosis, putting an emphasis in personalized care and active participation in the broader MPN community. He also goes on to emphasize the importance of consulting an MPN specialist to ensure optimal care.

, creating and managing programs, was recognized at the 

 for his dedication in uniting the patient, physician and pharmaceutical communities together in creating awareness for MPN research.

In an interview, Winneker sat down with CURE and shared his expert insights on patient care, as well as expanded on the importance of participation in groups like the MPN Research Foundation to ensure a high prioritization of research and collaboration across the field. Read more from the interview below.

The first thing I do when I meet a patient, rather than giving them advice right away, is ask them how they're doing. I want to understand what they're experiencing because I know it can be so different from one patient to the next. [However], my advice usually is: if possible, try to see an MPN specialist, if not directly, but perhaps a second opinion or a consultation of some kind. They're the ones that are really closely following this rapidly emerging field, [therefore] you want to make sure that you're experiencing the best possible outcomes that you can.

Secondly, I would say be your own best advocate. Not only that, [but] join the MPN Research Foundation. Work with us and be part of that solution that we're trying to bring forward. We want to hear from patients about what they care about most, in terms of what we should be doing next. See the right people and join us. I think that would be my message.

Among patients with breast cancer, low doses of the oral hair growth drug minoxidil — the active ingredient in over-the-counter Rogaine — taken during or after cancer treatment is associated with hair regrowth in patients and were not found to cause any serious heart-related side effects requiring additional therapies or hospitalization.

Researchers, led by a team from NYU Langone Health, published their findings in a research letter in the 

Journal of the American Academy of Dermatology.

“Based on these findings, minoxidil has been shown to be safe for patients while also being effective,” said co-senior author Dr. Kristen Lo Sicco, associate professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine, in a news release issued by NYU Langone Health. “The effectiveness of minoxidil may therefore help patients restore their sense of self and some control in a situation where it has been visibly taken away.”

 for patients with breast cancer who receive treatment with chemotherapy, researchers explained. While 5 milligrams or less of oral minoxidil daily is a promising off-label treatment for alopecia, concerns persist regarding potential cardiovascular side effects, particularly among patients who have received treatment with anthracyclines or Herceptin (trastuzumab), they reported.

The retrospective analysis of patients with breast cancer prescribed low-dose oral minoxidil for alopecia between Nov. 16, 2012, and June 19, 2023 — including 51 patients with a median age 67 years, of whom 25 (49%) received chemotherapy and 26 (51%) underwent surgery and/or radiation alone. Investigators found that all patients had improvement or stability of alopecia after three to six months of low-dose minoxidil, with no significant difference in treatment effectiveness between patients who underwent chemotherapy and those who did not.

At six months or longer, three patients who underwent chemotherapy reported worsening alopecia, with two of those patients having corroborating physician assessments, all three having had prior taxane exposure and two also receiving doxorubicin and cyclophosphamide.

Researchers reported that 29 patients (56.9%), experienced 44 side effects, with no significant difference in side effects between groups and the majority of side effects (61.4%) being hypertrichosis. No pericardial or life-threatening side effects were reported.

CURE spoke with Lo Sicco and co-lead author Devyn Zaminski, a medical student at NYU Grossman School of Medicine, via email about the findings.

CURE: For patients with breast cancer, what do you believe is the big takeaway from these findings?

 Women are already often held to a different standard compared with men without hair. It creates an additional vulnerability for someone who has already endured so much. Our hope is that this study will help to expand the treatment options for breast cancer survivors. 

 Hair loss can be a persistent and sometimes long-lasting external reminder of a woman's breast cancer experience. We hope that breast cancer survivors feel empowered in knowing there is a safe and effective solution for treating hair loss — offering relief without adding to the stress and challenges they have already endured. 

What separates these findings from previous research on this topic?

Low-dose oral minoxidil is effective for hair regrowth in breast cancer patients experiencing alopecia due to chemotherapy, without causing serious cardiovascular side effects. A study involving 51 patients showed improvement or stability in alopecia after three to six months of treatment. While some patients experienced side effects, none were life-threatening. The findings suggest that minoxidil can be a safe option for managing hair loss, potentially improving the quality of life for breast cancer survivors. Advocacy for insurance coverage of cranial prostheses is also emphasized.

Low-dose oral minoxidil, the hair growth drug that is the active ingredient in Rogaine, may be safe and effective for patients with breast cancer.

Dr. David A. Braun

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