News|Articles|April 16, 2026

Oral Chemotherapy Shows Success for Patients With Advanced Breast Cancer

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Key Takeaways

OPTIMAL randomized patients 1:1 to DHP107 200 mg/m² PO BID days 1/8/15 q28d or paclitaxel 80 mg/m² IV on the same schedule, stratified by DFI, visceral disease, and region.
Non-inferior PFS was achieved (PPS 10.0 vs 8.5 months), with similar OS (32.6 vs 31.8 months), ORR (43.3% vs 38.8%), DCR (89.2% vs 84.4%), and TTF (7.6 vs 7.4 months).
Severe toxicity rates were comparable (grade ≥3: 85.9% vs 86.8%), with high-grade neutropenia and leukopenia occurring at similar frequencies across oral and IV paclitaxel.
Lower neurotoxicity was observed with DHP107 (any-grade neuropathy 41.3% vs 53.3%; grade ≥3 1.1% vs 4.0%) alongside reduced alopecia (36.2% vs 51.5%).
Gastrointestinal adverse events were more frequent with DHP107 (nausea 26.8% vs 13.6%; diarrhea 21.0% vs 8.1%), while eliminating routine IV premedication and infusion-chair time.

The OPTIMAL trial finds oral DHP107 is as effective as IV paclitaxel for patients with advanced breast cancer while reducing side effects like neuropathy.

For patients with HER2-negative metastatic breast cancer, results of the phase 3 OPTIMAL trial have confirmed that DHP107, a novel oral paclitaxel formulation, is non-inferior to traditional intravenous (IV) paclitaxel chemotherapy.

From January 2018 to December 2023, researchers at 51 sites across South Korea, China and Europe evaluated 549 patients to determine if an oral regimen could match the efficacy of weekly IV infusions while reducing the clinical burden of prolonged administration and premedication. The results, published in Annals of Oncology, demonstrate that DHP107 successfully met its primary endpoint of progression-free survival (PFS), offering a viable alternative that eliminates the need for IV access and reduces the risk of peripheral neuropathy.

Main data that support the findings

The primary endpoint of investigator-assessed progression-free survival, or the time a patient lives without their disease spreading or worsening, met the predefined non-inferiority margin of 1.33. In the per-protocol set (PPS), the median PFS was 10 months for the DHP107 group compared to 8.5 months for those receiving IV paclitaxel.

Secondary endpoints further supported these findings:

Overall Survival (OS): The median OS, or the time a patient lives, was 32.6 months in the DHP107 group and 31.8 months in the IV paclitaxel group.
Tumor Response: The investigator-assessed objective response rate (ORR) was 43.3% for DHP107 versus 38.8% for IV paclitaxel. The disease control rate (DCR) was 89.2% and 84.4%, respectively.
Quality of Life (QoL): EQ-5D-3L index and EQ-VAS scores remained comparable between the two groups throughout the treatment cycles, showing no meaningful decline until the end of treatment.
Time to Treatment Failure (TTF): The median TTF was 7.6 months for the oral group and 7.4 months for the IV group.

Trial details

The OPTIMAL trial enrolled 549 patients who were randomized 1:1 to receive either DHP107 (277 patients) or IV paclitaxel (272 patients). Eligible participants were aged 19 years or older with histologically confirmed HER2-negative recurrent or metastatic breast cancer. Patients must not have received prior chemotherapy for metastatic disease, though prior taxane use in the (neo)adjuvant setting was permitted if completed at least one year before randomization.

Patients in the DHP107 group received 200 mg/m² orally twice daily on days 1, 8 and 15 of a 28-day cycle. Those in the IV group received 80 mg/m² intravenously on the same schedule. While premedication was mandatory for the IV group to prevent hypersensitivity reactions, it was not required for the DHP107 group. Randomization was stratified by disease-free interval, presence of visceral metastasis and geographic region.

Safety

Treatment-emergent side effects of grade 3 (severe) or higher occurred in 85.9% of the DHP107 group and 86.8% of the IV paclitaxel group. The most common grade 3 or higher hematologic toxicities for DHP107 and IV paclitaxel, respectively, included neutropenia (79% versus 80.5%) and leukopenia (43.1% versus 41.2%).

Importantly, the oral formulation was associated with a lower incidence of certain side effects. Peripheral neuropathy, a common concern for patients receiving taxanes, occurred at a lower rate in the DHP107 group compared to the IV group (any grade: 41.3% versus 53.3%; grade 3 or higher: 1.1% versus 4.0%). Additionally, treatment-related alopecia (hair loss) was reported less frequently in patients receiving the oral medication (36.2% versus 51.5%).

However, gastrointestinal issues were more frequent in the DHP107 group, including any-grade nausea (26.8% versus 13.6%) and diarrhea (21% versus 8.1%). Fatal side effects were rare, occurring in 1.1% of the oral group and 0.4% of the IV group. By offering a treatment that can be taken at home, DHP107 may significantly reduce the clinical burden on patients who would otherwise require lengthy clinical visits for IV administration.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

Reference:

“OPTIMAL: A Multinational Phase III Study of Oral Paclitaxel (DHP107) versus Intravenous Weekly Paclitaxel in HER2-Negative Recurrent or Metastatic Breast Cancer” by Dr. B. Xu, Dr. H. Jeong and Dr. T. Sun, et al., Annals of Oncology.

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