The 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI) took place from January 23 to 25 in San Francisco, bringing together the latest advancements in digestive tract oncology. Paclitaxel remains one of the most important chemotherapeutic agents for gastric cancer treatment. However, the traditional intravenous (IV) formulation has long been associated with significant adverse effects. Chinese researchers have continued to optimize the structure and formulation of paclitaxel, aiming for better efficacy and safety, ultimately leading to the successful development and approval of the world's first oral paclitaxel solution.At this year’s ASCO GI, Dr. Jin Li from Shanghai GoBroad Cancer Hospital, along with Dr. Shukui Qin from Nanjing Tianyinshan Hospital, led the presentation of a phase III clinical study comparing oral paclitaxel solution to IV paclitaxel as second-line therapy for advanced gastric cancer. The study results highlighted better treatment outcomes and favorable safety profiles, offering a more convenient option for patients worldwide.
Paclitaxel in Gastric Cancer Treatment
Oncology Frontier: What is the current role of paclitaxel in gastric cancer treatment?
Dr. Jin Li: Paclitaxel remains one of the most essential chemotherapeutic agents in gastric cancer treatment. The main chemotherapy options for gastric cancer include platinum-based agents (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel, albumin-bound paclitaxel), and fluoropyrimidines (capecitabine, S-1, 5-FU). Currently, combinations of paclitaxel with fluoropyrimidines or platinum with fluoropyrimidines are standard first-line treatment regimens.
In China, first-line gastric cancer treatment primarily consists of oxaliplatin combined with fluoropyrimidines, as oxaliplatin’s primary toxicity—cumulative peripheral neuropathy—is relatively mild in the initial cycles, allowing for better patient tolerance. Compared to taxanes, oxaliplatin provides a more tolerable option, enabling longer treatment duration, which is a key strategy for optimizing patient outcomes.
When platinum-based chemotherapy fails, docetaxel or paclitaxel is typically used as standard second-line therapy. Compared to conventional IV paclitaxel, albumin-bound paclitaxel has similar efficacy but a lower incidence of hypersensitivity reactions and acute toxicities, making it a preferred option among clinicians. Ramucirumab-based combinations are also an alternative second-line treatment, though they do not significantly improve overall survival (OS) despite showing progression-free survival (PFS) benefits. However, ramucirumab is not yet covered by China’s national insurance program, making taxanes (paclitaxel, albumin-bound paclitaxel, or docetaxel) the more accessible options for many patients.
Clinical Trial Results on Oral Paclitaxel Solution at ASCO GI
Oncology Frontier: At this year’s ASCO GI, your team presented a study on oral paclitaxel solution. Could you elaborate on its design and findings?
Dr. Jin Li: As mentioned, IV paclitaxel, albumin-bound paclitaxel, and docetaxel are all standard second-line chemotherapy options for gastric cancer. However, because these drugs require IV administration, they often necessitate the placement of chemotherapy pumps, peripheral venous catheters, or infusion ports, making treatment both invasive and inconvenient for patients.
Our goal was to develop a more patient-friendly oral chemotherapy option. This led to the head-to-head phase III clinical trial comparing standard IV paclitaxel with oral paclitaxel solution for second-line treatment of advanced gastric cancer.
Initially, our expectation was for oral paclitaxel to serve as a non-inferior substitute for IV paclitaxel while also offering a potential improvement in PFS. One of the key advantages of oral paclitaxel is the ability to adjust or stop treatment at any time to manage toxicities, whereas IV paclitaxel is administered in a single infusion, meaning that patients must endure chemotherapy-related toxicities until the next cycle before dose modifications can be made.
With oral paclitaxel, patients can self-manage toxicities in real-time, allowing for better adherence and potentially extended PFS.
The final study results demonstrated that oral paclitaxel solution not only showed numerical improvements in PFS compared to IV paclitaxel (median PFS: 3.02 months vs. 2.89 months; HR = 0.894, 95% CI: 0.719-1.112, P = 0.311) but also significantly improved median OS (median OS: 9.13 months vs. 6.54 months; HR = 0.770, 95.5% CI: 0.635-0.934, P = 0.006).
Additionally, oral paclitaxel exhibited a lower incidence of adverse effects, leading to better patient tolerance and prolonged survival.
I firmly believe that oral paclitaxel solution will become the standard second-line treatment for gastric cancer in China. This study reinforces the idea that even in the era of targeted and immunotherapy, innovations in traditional chemotherapy formulations remain highly valuable, offering patients both longer survival and improved quality of life.
Mechanism and Clinical Advantages of Oral Paclitaxel Solution
Oncology Frontier: What is the underlying mechanism that makes oral paclitaxel solution advantageous?
Dr. Jin Li: The mechanism of oral paclitaxel is based on dissolving the drug in an oil emulsion, allowing it to be absorbed through the digestive tract when taken orally. Unlike intravenous (IV) paclitaxel, which directly enters the bloodstream, oral paclitaxel solution must first be absorbed into the body to exert its antitumor effects.
One of its advantages is that it has only a slightly higher gastrointestinal toxicity than IV paclitaxel, and most patients tolerate it well. Additionally, oral paclitaxel has a longer half-life, meaning that it remains in the bloodstream for an extended period.
Since paclitaxel is a cell cycle-specific drug, maintaining a stable and effective drug concentration over time enhances its ability to block more tumor cells from entering the proliferation phase, thereby exerting a stronger and more sustained antitumor effect. This prolonged exposure to paclitaxel in the bloodstream is a key factor in its potential to provide greater therapeutic benefits for patients.
Future Prospects for Clinical Application of Oral Paclitaxel Solution
Oncology Frontier: What are your expectations for the future clinical application of oral paclitaxel solution?
Dr. Jin Li: The National Medical Products Administration (NMPA) of China has already approved the market launch of oral paclitaxel solution, and I firmly believe that it will soon become widely accessible in clinical practice.
Previously, for patients who were unable to visit the hospital frequently for IV infusions, we sometimes opted for weekly IV paclitaxel administration as a more practical alternative. Now, with the availability of oral paclitaxel solution, patients can complete their chemotherapy cycles at home, eliminating the need for frequent hospital visits and significantly reducing the physical and logistical burden on them.
Gastric cancer patients often experience poor physical condition and limited stamina, making repeated hospital visits exhausting. Oral paclitaxel solution provides a more convenient treatment option, allowing patients to conserve their strength while continuing their therapy at home.
I am confident that, in the near future, China’s National Healthcare Security Administration will include oral paclitaxel solution in the national insurance program, making it more affordable and accessible for a broader patient population. We eagerly anticipate that day, as it will bring a more convenient, cost-effective, efficacious, and safer treatment option to cancer patients.
About Dr. Jin Li
Dr. Jin Li
- President, Shanghai GoBroad Cancer Hospital, China Pharmaceutical University
- Lifetime Professor, Shanghai East Hospital, Tongji University
- President, Federation of Asian Clinical Oncology (FACO)
- Vice Supervisor, Chinese Society of Clinical Oncology (CSCO)
- Chairman, CSCO Foundation
- Chairman, Tumor Clinical Research Committee, China Pharmaceutical Innovation and Research Development Association
- Vice Chairman, National Health Commission Oncology Expert Committee
- Former President, CSCO
- Chairman, CSCO Gastric Cancer Expert Committee
- President-Elect, CSCO Colorectal Cancer Committee
- Deputy Editor-in-Chief, Cancer Science
