Rone Discusses Exciting Immunotherapy Research in Gastrointestinal Cancer


Kelley A. Rone, DNP, RN, ADNP-c, highlights the pivotal trials assessing the role of immunotherapy in gastrointestinal cancer and what the findings may mean for oncology nurses.

Kelley A. Rone, DNP, RN, ADNP-c

Kelley A. Rone, DNP, RN, ADNP-c

Although the use of immunotherapy in gastrointestinal (GI) cancers is still limited, new research is bringing this treatment approach to the forefront, according to Kelley A. Rone, DNP, RN, AGNP-c, a nurse practitioner at Mayo Clinic in Arizona.

“The addition of immunotherapy will [hopefully] give a boost to some of these difficult-to-treat cancers,” said Rone, who recently gave a presentation on advances in GI cancers as part of the 6th Annual School of Nursing Oncology®. In an interview with Oncology Nursing News®, she discusses how immunotherapy represents a promising avenue for many patients in this population.

According to Rone, 3 recently published studies are changing the landscape of GI oncology. These include the CheckMate 648 trial (NCT03143153),1 which assessed nivolumab (Opdivo) plus ipilimumab (Yervoy), and nivolumab plus chemotherapy, against chemotherapy alone in patients with esophageal squamous cell carcinoma (ESCC); the MOUNTAINEER trial (NCT03043313),2 in which tucatinib (Tukysa) combined with trastuzumab (Herceptin) was evaluated in patients with HER2-positive metastatic colorectal cancer; and TOPAZ-1 (NCT03875235), a head-to-head trial of durvalumab (Imfinzi) in combination with gemcitabine plus cisplatin vs chemotherapy alone in patients with advanced biliary tract cancer.3

Findings from CheckMate 648 showed that the addition of immunotherapy in the frontline treatment of ESCC improved overall survival (OS) in the intention-to-treat population. The median OS with nivolumab plus ipilimumab was 12.8 months (95% CI, 11.3-15.5) and 13.2 months (95% CI, 11.1-15.7) with the chemoimmunotherapy regimen. These were compared with patients treated in the chemotherapy alone arm who had a median OS of 10.7 months (95% CI, 9.4-11.9). The reduction in risk of death was 22% (HR, 0.78; 95% CI, 0.65-0.95; P = .0110) and 26% (HR, 0.74; 95% CI, 0.61-0.90; P = .0021), respectively. The OS benefit was consistent across subgroups, irrespective of PD-L1 status.1

“We used to not have a lot of immunotherapy options for our [patients with] GI cancer,” Rone said. “We still only use immunotherapy in colon cancer or pancreas cancer if [it is] microsatellite instability–high, but we are seeing more immunotherapy used in ESCC.” She added that although patients with ESCC used to require PD-L1 tumor positivity to receive immunotherapy, new findings have shown that this is no longer necessary, and more patients are able to receive immunotherapy along with chemotherapy.

Data from the phase 2 MOUNTAINEER trial, presented at the 2022 ESMO World Congress on Gastrointestinal Cancer (World GI) showed that patients with previously treated metastatic HER2-positive colorectal cancer had a sustained response to treatment with dual-HER2 inhibitors tucatinib plus trastuzumab.2 Specifically, among 84 treated patients the confirmed objective response rate by blinded independent central review was 38.1% (95% CI, 27.7%-49.3%). Further, at a median follow-up of 20.7 months, the median progression-free survival was 8.2 months (95% CI, 4.2-10.3) with a median OS of 24.1 months (95% CI, 20.3-36.7).2

Data from phase 3 TOPAZ-1 trial presented at the 2022 ASCO Annual Meeting showed a 20% reduction in the risk of death with durvalumab plus chemotherapy vs placebo plus chemotherapy for patients with biliary tract cancer (HR, 0.80; 95% CI, 0.66-0.97; P = .021).3

“The use of immunotherapy to treat something like cholangiocarcinoma is very intriguing to me,” Rone remarked. “I just saw our first patient this week who had durvalumab added to her gemcitabine and cisplatin. That opens up a lot of doors for patients, because chemotherapy plus immunotherapy seems to have better longevity for [patients with] cholangiocarcinoma.

“Sometimes if we can treat with the combination of chemotherapy and immunotherapy initially, then, at some point, we can drop the chemotherapy and use immunotherapy alone to keep the cancer stable,” she explained. “Immunotherapy, in general, is much more tolerable [for] patients. It does not cause all the toxicities that chemotherapy does.”

Rone cautioned that, when administering immunotherapy to patients, there are some key factors to keep in mind. In addition to other immune-related adverse events, patients will likely experience diarrhea with this treatment modality, and joint pain is also quite prevalent. According to Rone, nurses need to stay abreast of these possibilities and to patients directed questions to determine if they are being affected by these toxicities.

“You have to be aware of kind of the subtle immune-mediated toxicities that can occur and you [need] to ask more directed questions,” she concluded.


1. Chau I, Doki Y, Ajani JA, et al. Nivolumab (NIVO) plus ipilimumab (IPI) or NIVO plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced esophageal squamous cell carcinoma (ESCC): first results of the CheckMate 648 study. J Clin Oncol. 2021;39(suppl 15):LBA4001. doi:10.1200/JCO.2021.39.15_suppl.LBA4001

2. Seagen announces results from pivotal MOUNTAINEER trial demonstrating clinically meaningful antitumor activity of Tukysa (tucatinib) in combination with trastuzumab in previously treated HER2-positive metastatic colorectal cancer. News release. Seagen Inc. July 2, 2022. Accessed August 1, 2022.

3. Oh DY, He AW, Qin S, et al. A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1. J Clin Oncol. 2022;40(suppl 4):378. doi:10.1200/JCO.2022.40.4_suppl.378

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