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As part of our coverage of ASCO’s 2017 Gastrointestinal Cancers Symposium held January 19th to the 21st in San Francisco, today we are speaking with Dr. Geoffrey Ku, MD, a medical oncologist with Memorial Sloan Kettering Cancer Center specializing in gastrointestinal malignancies. At this year’s meeting, Dr. Ku will be participating in an education session on advances in systemic therapy for esophageal and gastric cancer.

Dr. Ku, your portion of the session will focus on immunotherapy. Immunotherapy is still somewhat new to the cancer scene, and is most commonly discussed in relation to melanoma, kidney, or lung cancers. How does research into immunotherapy for gastric and esophageal cancers compare with the progress in these other solid tumors? 

 Thanks for the question and I really appreciate the opportunity to discuss this. A part of the excitement is that while immunotherapy is certainly new the recognition is that in many different cancers it really is the most exciting development in last 20 or 30 years.

As you know, the premise is that we are giving drugs that essentially stimulate the immune system so that the immune system is able to recognize and attack cancer cells. These drugs were initially developed in melanoma, but over the space of 5 to 6 years there are now FDA-approved indications in many other common cancers including lung as well as bladder cancer. I would say that in esophageal and gastric cancer development of these drugs lags a little behind lung cancer, but there are certainly phase III studies that are ongoing.

In fact, at the Gastrointestinal Cancers Symposium there will be the results of a phase III study of one of these drugs that will be presented. At this point, we only have little bits of information, but the press release does suggest that it is a positive study that found clear benefit for one of the immune drugs versus placebo. That really is a milestone development in esophageal/gastric cancer.

Do any specific types of gastric or esophageal cancers or subgroup of patients appear to benefit more from immunotherapy approaches?

 That is certainly more than $64,000 question. It is the $640 million question. I think it is clear not only in esophageal/gastric cancer, but in other cancers that do respond to immune treatment that there are subgroups of patients who appear to derive more benefit than others. Certainly we think that one of the most helpful biomarkers, at this point, is a protein called PD-L1. PD-L1 is a target for many of these immune drugs. In esophageal/gastric cancer it is found about 40% of time. When it is present, it significantly increases the chance of shrinkage and response to these immune treatments. That is potentially one way to help select patients. Part of challenge of using PD-L1 is that even when it is not present there still are some patients who can benefit.

That is one important biomarker, but at the same time, we also know that, in general, the immune system is better able to recognize cancer cells that appear very abnormal. The more mutations that a cancer cell has the more likely it is to be recognized by the immune system. This remains an area of active development, but we are all trying to figure out how we can best figure out how abnormal cancer cells looks like, how many mutations they have.

Certainly, the thought is that markers like PD-L1, markers like the amount of mutations that are found in the cancer cells may allow us to fine tune who is and is not likely to benefit from these medications because while they are active, the reality is that they really only do benefit a minority of patients. They can have significant side effects, which involve inflammation of essentially any part of the body. That is what happens when the immune system becomes super activated.

Among the different immunotherapeutic approaches, research of immune checkpoint inhibitors have shown the most promise, what trials have looked into these drugs in gastrointestinal cancers and what have the results shown so far?

 There are a number of drugs that are all relatively similar. They all work by blocking a pathway known as PD-1/PD-L1. This is a pathway that we think helps to lower the immune system. We think that it is one way that cancer cells are able to evade the immune system after the immune system initially recognizes them. There are four or five different drugs that are being looked at and they are all antibodies. They are proteins that block this pathway. Representative drugs include pembrolizumab, nivolumab, and avelumab.

At this point in time, there are probably anywhere from five to seven, potentially even more, complementary phase III studies that are ongoing. As I mentioned, the one study that will be presented in about 10 days at the Gastrointestinal Cancers Symposium involves a drug called nivolumab, which blocks a protein called PD-1. In a study of about 450 patients-it was done mostly in East Asia-nivolumab helped patients live longer than patients who received placebo. Certainly, nivolumab is a leading contender, but pembrolizumab, which is a very similar drug, is also currently being looked at in multiple phase III studies, some of which are complete and potentially for which we will have results over the next 1 or 2 years.

Looking to the future, what areas are yet to be explored and what clinical trials are the most eagerly awaited in this area?

There are really many phase III studies that are ongoing. These are studies all in the advanced setting. Patients who have cancer that has spread in the first place, or cancer that recurred after a combination of surgery, chemotherapy, or radiation. There are studies in the first-line setting, meaning patients who have not received any previous treatment. There are studies in the second-line setting, meaning for patients for whom the cancer has grown on one treatment. They are either looking at these immune drugs on their own or they are comparing them to standard chemotherapy. Any number of these phase III studies have results that are eagerly awaited.

In terms of looking to the future, it is a combination of some of the things that we discussed. The one thing I would emphasize is that despite the promise and the excitement of these drugs, it is a relative minority of patients that benefit. Approximately only 15% of all patients benefit from these immune treatments. Part of the goal as we move forward is trying to identify biomarkers or tests that can help us to figure out who falls into the 15% of patients.

Careful patient identification to select patients who are most appropriate for the treatments so that we minimize exposing patients who are not likely to benefit from these treatments is definitely a priority. At the same time, the second generation studies, which are already slowly beginning, are beginning to look at combination strategies with the premise that potentially two drugs are better than one, or two ways of activating the immune system is better than one. This is an approach that is born out in other cancers, including melanoma and lung cancer, but the idea now is to begin to look at two drugs that activate the immune system or a combination of immunotherapy with chemotherapy, or even combining these drugs with radiation. There is some thought that if we treat a tumor with radiation and we are able to kill the tumor cells and the contents of the tumor cells are released, an immune system that is already activated is better able to recognize them.

These are all new strategies that are slowly underway. To the degree that immunotherapy has transformed the treatment of many other cancers, it is on the verge of transforming esophageal and stomach cancer. With the second-generation studies, we will see in the next 5 to10 years an improvement or an increase in the number of patients who will benefit and also an increased ability to better identify patients who will benefit.

I want to thank you again for speaking with us today and providing this update in immunotherapy in esophageal and gastric cancers. 

ASCO Gastrointestinal Cancer Symposium

Ahead of the 2017 ASCO Gastrointestinal Cancer Symposium in San Francisco, we spoke with Dr. Geoffrey Ku on the advances in systemic therapy for esophageal and gastric cancer.

Immunotherapy Treatments Only Just Emerging in Esophageal, Gastric Cancers

T-DXd improved OS, PFS, ORR, and DOR vs ramucirumab plus paclitaxel in the second-line treatment of HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma. 

T-DXd Emerges as New Standard of Care for Second-Line HER2+ Gastric/GEJ Cancer 

Antitumor activity was observed in patients with gastroesophageal adenocarcinoma treated with the combination regardless of chemotherapy type.

Zanidatamab Displays Safety, Efficacy in HER2-Expressing Gastric Cancer

The safety profile of TFOX was consistent with data reported in previous studies, and no new safety signals were identified.

TFOX Regimen Enhances Efficacy vs FOLFOX in HER2-Negative Gastric Cancer

Pathological complete response was higher among patients with ERBB2–positive gastric cancer or GEJ adenocarcinoma treated with atezolizumab vs without.

Atezolizumab/Trastuzumab Plus Chemotherapy Shows Efficacy in Gastric Cancer

Results from the phase 2/3 trial also show a favorable OS trend for KN026 with chemotherapy vs placebo with chemotherapy in HER2-positive gastric cancer. 

KN026/Chemotherapy Meets PFS End Point in HER2+ Gastric Cancer in 2L Setting

Prolonging systemic therapy in patients with gastric or gastroesophageal junction cancers may offer better outcomes than radiation therapy.

Radiation Therapy Does Not Improve Survival in Gastric/GEJ Cancers

CancerNetwork® spoke with Yelena Y. Janjigian, MD, chief attending physician of the Gastrointestinal Medical Oncology Service at Memorial Sloan Kettering Cancer Center, about developments in gastric or gastroesophageal junction (GEJ) cancers that she believes has the potential to change clinical practice.

Highlighting results from 2 clinical trials—the phase 3 TOPGEAR (NCT01924819) and the phase 3 ESOPEC (NCT02509286) trials—Janjigian stated that radiation therapy in patients with gastric and GEJ cancers will not improve survival in this population.

Furthermore, she expressed that for immunotherapy in the perioperative setting, the fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) regimen was the optimal therapy. She added that in the event that FLOT was unable, dose reductions or the removal of docetaxel were viable treatment strategies. Furthermore, she advised against the use of another combination, known as the CROSS regimen, which is composed of paclitaxel plus carboplatin (CarboTaxol) plus radiation, in patients with gastric or GEJ cancers.

Janjigian explained that patients should not be rushed to undergo radiation therapy if they are unable to receive an R0 resection, instead suggesting prolonged systemic therapy with either a triplet or a doublet regimen with immunotherapy. Only after the disease biology declares itself should one consider performing surgery. She concluded by emphasizing that FLOT with durvalumab (Imfinzi) is the optimal regimen to treat this systemic disease in the perioperative setting.

Other developments in gastric and esophageal cancer that are critical to recognize are that we have now had 2 randomized studies published in the 

, just in the past year: the phase 3 TOPGEAR study and the phase 3 ESOPEC study showing that radiation does not improve survival in these patients. Radiating the gastroesophageal junction or stomach will not help your patients live longer.

The critical piece to [remember] is that you cannot radiate with FLOT, and if you are going to use immunotherapy in the perioperative setting, FLOT is the best option. If the patient is not able to get FLOT, if you want to dose reduce once you get started or drop docetaxel, that’s okay. One important factor to [remember] is that for adenocarcinoma, the CROSS regimen, or [paclitaxel plus carboplatin (CarboTaxol)] plus radiation, should never be used. I have not used this regimen in over 6 years. That [is an] important development: that radiation does not improve survival.

If the patient is not able to get a complete resection or R0 resection––sometimes oncologists say, “we radiated because the R0 section was not possible.” That’s not the patient that you should be rushing to the [operating room] with; radiation will not help this patient live longer. You need to prolong systemic therapy, perhaps starting with either a triplet with immunotherapy or a doublet with immunotherapy. Only once the disease biology declares itself you could consider doing surgery. 

The reason why the R0 resection rates are [higher] with radiation but do not translate to survival benefit is because this disease is systemic in nature. If you do not recognize that you are doing your patients a disservice and are ignoring the big factor that in patients who [receive radiation], R0 resection does not translate to survival benefit, that is the critical point. We need to treat systemic disease, and in the perioperative setting, FLOT plus durvalumab offers that important option.

Leong T, Smithers BM, Michael M, et al. Preoperative Chemoradiotherapy for Resectable Gastric Cancer. 

 2024;391(19):1810-1821. doi:10.1056/NEJMoa2405195

Hoeppner J, Brunner T, Schmoor C, et al. Perioperative chemotherapy or preoperative chemoradiotherapy in esophageal cancer. 

 2025;392(4):323-335. doi:10.1056/NEJMoa2409408

Videos

Most adverse effects observed in combination therapies for gastric cancers are associated with chemotherapy, according to Yelena Y. Janjigian, MD.

Durvalumab Plus FLOT May Not Significantly Increase AEs in Gastric Cancer

Most adverse effects (AEs) observed in previously published interim 

 results, assessing durvalumab (Imfinzi) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT), come from chemotherapy, according to Yelena Y. Janjigian, MD.

CancerNetwork® spoke with Janjigian, chief attending physician of the Gastrointestinal Medical Oncology Service at Memorial Sloan Kettering Cancer Center, about how the AE profile of durvalumab in combination with FLOT compared with that of chemotherapy alone in patients with resectable locally advanced gastric and gastroesophageal junction (GEJ) cancers.

She initially expressed that previously exhibited interim results from the phase 3 MATTERHORN trial showed that chemotherapy accounted for the majority of AEs in patients receiving durvalumab plus FLOT. Additionally, she added that immune-related AEs from anti–PD-1 or anti–PD-L1 agents happen infrequently but may be serious if observed.

Janjigian reiterated the idea that chemotherapy accounted for most AEs with combination therapy by highlighting results from the phase 2/3 FLOT-4 trial (NCT01216644).

Furthermore, she touched upon potential immune-related AEs, as well as skin toxicities, before explaining that the greatest difficulty regarding the safety profile of the durvalumab/FLOT regimen will be in administering FLOT safely.

Additionally, Janjigian supported the utilization of dose reduction and antiemetics such as olanzapine (Zyprexa) for AE management in this patient population, particularly dose reduction with or without growth factor support to help mitigate white blood cell count decreases. Citing previous success with managing the safety profile of adjuvant nivolumab with chemotherapy in patients with a high risk of recurrence from gastric or GEJ cancers, she suggested that the same could be expected from the durvalumab combination regimen in MATTERHORN.

Previous safety results from the phase 3 MATTERHORN trial revealed that the safety profile of durvalumab and FLOT were comparable with prior reports of each respective agent.

In terms of the [adverse] effects of chemotherapy in general, we know from the metastatic setting and also from the data that were already presented from the MATTERHORN study—which is [assessing] the FLOT plus durvalumab combination–that most of the adverse effects come from chemotherapy. The immune-related [adverse] effects from anti–PD-1 or anti–PD-L1 agents are relatively rare but could be serious.

When we think about a triplet combination, most of the [adverse] effects are from the chemotherapy because you are giving them fluoropyrimidine, oxaliplatin, and docetaxel. If an oncologist is able to give these drugs and has done that in their practice for quite some time—which we have; the [phase 2/3] FLOT-4 data came out years ago, and since then, those of us that see this disease have been using FLOT—the addition of durvalumab does not cause [many adverse] effects.

You could have immune-related [adverse] effects, which can commonly affect the skin, or other mild [adverse] effects. You could have endocrinopathies, thyroid abnormalities, and glucose metabolism abnormalities. But most of the [adverse] effects are well managed. The steepest learning curve will be managing and [administrating] FLOT safely. Certainly, that’s doable.

Dose reductions are our friend and our patients’ friend, [as well as] antiemetics––using drugs like olanzapine as an antiemetic per the ASCO guidelines. Perhaps using dose reductions and/or a growth factor support for a patient who will [experience] decreases in white blood cell count will be important.

Suffice to say, the data suggest that you could do it––that’s what we have already seen. Durvalumab maintenance, [which patients continue for 1 year following surgery], is also part of what the patients are already getting used to because of the culture of high-risk disease recurrence. We have done that with adjuvant nivolumab now, and so we do not anticipate any issues with that approach.

IMFINZI® (durvalumab)-based regimen demonstrated statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers. News release. AstraZeneca. March 7, 2025. Accessed March 12, 2025. https://tinyurl.com/mr4cxyzd

Al-Batran SE, Homann N, Pauligk C, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. 

 2019;393(10184):1948-1957. doi:10.1016/S0140-6736(18)32557-1

Advances in perioperative targeted therapies may enable organ preservation and significantly enhance outcomes for patients with gastric cancers.

Bringing Immunotherapy to Earlier Stages of Gastric/GEJ Cancer

CancerNetwork® spoke with Yelena Y. Janjigian, MD, chief attending physician of the Gastrointestinal Medical Oncology Service at Memorial Sloan Kettering Cancer Center, about the unmet need durvalumab (Imfinzi) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) would help reduce in patients with resectable locally advanced gastric and gastroesophageal junction (GEJ) cancers.

Janjigian began by explaining that the regimen was seeking to address a need for perioperative targeted therapy in this patient population. She contextualized the feasibility of the durvalumab plus FLOT regimen by highlighting findings from the phase 3 CheckMate 577 study (NCT02743494), where adjuvant nivolumab (Opdivo) reduced the risk of cancer recurrence in patients with high-risk disease and residual lymph nodes or tumors at the time of surgery.

FDA approval of nivolumab for resected esophageal or GEJ cancer

Additionally, Janjigian further expressed that neoadjuvant therapy before surgery was observed to benefit multiple disease states, and that neoadjuvant treatment biologically expands the T-cell population and helps survey cancer post-surgery. She then explained that in certain disease states, such as microsatellite instability–high (MSI-H) tumors, organ preservation without surgery may be feasible. She further remarked that the presence of positive data for therapy in the perioperative setting can serve to shift the paradigm for this patient population.

Furthermore, Janjigian speculated that organ preservation may be possible for complete responders to neoadjuvant immunotherapy with gastric or GEJ cancers, highlighting previous data which showed that chemotherapy in combination with immunotherapy has treated metastatic cancers and has been approved in stage IV disease.

 was seeking to assess immunotherapy in early-stage disease with curative intent, even before surgery.

The unmet need that that this regimen is helping to address is perioperative targeted therapy. [When] it’s chemoradiation followed by surgery, and if [the patient has] high-risk disease for recurrence with residual lymph node or residual tumor at the time of surgery, we know that adjuvant nivolumab helps reduce risk of cancer recurrence. That’s based on the phase 3 CheckMate 577 data.

 It is FDA-approved in that high-risk population.

In every other solid tumor—lung cancer, bladder cancer, [breast cancer], and other diseases—we know that doing neoadjuvant therapy before surgery helps patients have a better outcome [and] potential downstaging. In fact, the T-cell population biologically expands and helps survey the cancer even after surgery. In some diseases, we are now moving toward a non-operative approach, especially for [MSI-H] tumors. If there’s a complete response, perhaps you can do organ preservation and not have surgery. To have a positive study in the perioperative therapy setting––before surgery for gastric and esophageal adenocarcinoma––is truly remarkable because it can change the paradigm. We can shift the paradigm.

We can treat the patient as soon as they are diagnosed and not wait to give them immunotherapy after surgery. Also, perhaps it is within our lifetime that we can do organ preservation, where people can keep their organs and not live with lifelong sequela of having a major operation, especially if they had a complete response. We know that immunotherapy has worked in metastatic disease and that regimen, the 2-drug combination [of leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX)] plus immunotherapy has been approved for some time in stage IV disease. The unmet need that the phase 3 MATTERHORN study is addressing is bringing immunotherapy to early-stage disease in a curative setting and doing it even before surgery.

Kelly RJ, Ajani JA, Kuzdal J, et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. 

 2021;384(13):1191-1203. doi:10.1056/NEJMoa2032125

FDA approves nivolumab for resected esophageal or GEJ cancer. FDA. May 20, 2021. Accessed March 12, 2025. https://tinyurl.com/4wcvk3ud

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma. FDA. April 16, 2021. Accessed March 12, 2025. https://tinyurl.com/3f67jdtp

Panelists discuss how future analyses in advanced gastric cancer should assess long-term survival, real-world outcomes, biomarkers for response, resistance mechanisms, and patient selection for nivolumab plus chemotherapy. Evaluating these factors will optimize treatment strategies and confirm its role across diverse populations.

Key Takeaways and Future in Advanced Gastric Cancer Treatment

What are some key takeaways from this discussion?

What will be important to evaluate in future analyses in advanced gastric cancers?

Video Series

Panelists discuss how the 5-year survival data for nivolumab plus chemotherapy underscore its sustained efficacy as a first-line treatment, showing durable benefits over alternatives. Further research, including real-world evidence and broader clinical trials, is needed to validate its long-term impact across diverse patient populations and cancer subtypes.

Advancing First-Line Treatment Strategies in Gastric and Esophageal Cancers

What insights do the 5-year survival data for nivolumab plus chemotherapy provide when considering its efficacy alongside other first-line treatments for these cancers?

​What additional research or real-world evidence might be needed to further solidify the role of nivolumab plus chemotherapy based on these findings?

Panelists discuss how balancing treatment intensity with quality of life remains a critical challenge in advanced gastric cancers (GCs) and how implementing biomarker-driven approaches such as PD-L1 combined positive score (CPS) testing faces practical hurdles in clinical settings. Key considerations include optimizing patient outcomes while managing adverse effects and addressing barriers such as testing accessibility, result turnaround time, and standardization of biomarker interpretation.

Balancing Treatment Intensity, Quality of Life, and Biomarker-Driven Approaches in Advanced GI Cancers

How might these findings shape discussions about the balance between treatment intensity and maintaining patients’ quality of life in advanced GC/gastroesophageal junction cancer/esophageal adenocarcinoma?

What barriers might exist in applying biomarker-driven approaches, such as PD-L1 CPS, in real-world clinical settings, and how can they be addressed?

Panelists discuss how the adoption of immunotherapy-chemotherapy combinations in clinical practice requires careful consideration of both long-term safety profiles and sustained efficacy data. A 5-year follow-up period generally provides valuable insights into delayed adverse events and durability of response, which helps inform risk-benefit assessments. The balance between safety and efficacy should be evaluated on a patient-specific basis, considering factors such as performance status, comorbidities, and tumor characteristics.

Assessing the Long-Term Safety and Efficacy of Nivolumab Plus Chemotherapy for Broader Clinical Adoption in Advanced GI Cancers

Does the long-term safety profile of nivolumab plus chemotherapy at 5 years provide sufficient reassurance for broader adoption in clinical practice?

Panelists discuss how the long-term follow-up data from CheckMate649 are crucial for understanding the durability of nivolumab plus chemotherapy’s benefit in first-line advanced gastric cancers (GCs)/gastroesophageal junction cancers (GEJCs). The survival outcomes help validate this regimen’s position as a standard of care, particularly for patients with PD-L1 combined positive score (CPS) ≥ 5. Although the magnitude of benefit varies by PD-L1 expression, both overall survival (OS) and progression-free survival (PFS) data inform personalized treatment decisions, with stronger evidence supporting immunotherapy use in higher PD-L1–expressing tumors while maintaining use across most patient subgroups.

Evaluating Long-Term Outcomes and Personalized Treatment Strategies in Advanced Gastrointestinal Cancers

Please comment on the significance of a 5-year update for CheckMate649.

How might this affect your current clinical practice?

How do the OS and PFS benefits at 5 years reinforce or challenge nivolumab plus chemotherapy as the standard first-line treatment for this patient population?

How might the OS benefit in subgroups, particularly those defined by PD-L1 CPS thresholds, guide personalized treatment strategies for advanced GC/GEJC/esophageal adenocarcinoma?

Gastric Cancer

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