Evidence map›Paper›PMID 34925553›Full record

ArticleTherapeutic advances in medical oncology2021

Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study).

Sung-Bae Kim, Jae Hong Seo, Jin-Hee Ahn, Tae-Yong Kim, Seok Yun Kang, Joohyuk Sohn, Yaewon Yang, Kyong Hwa Park, Yong Wha Moon, Seungtaek Lim and 4 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in medical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03315364 (A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel®), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03315364 phase2 / phase3active not recruitingnot on this map

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

TypeinterventionalSponsorDaehwa Pharmaceutical Co., Ltd.Ran2017 to 2028Enrolled549ConditionsRecurrent or Metastatic Breast CancerArmsOral paclitaxel, Paclitaxel injection
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 1 country.

Sung-Bae KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, South Korea.
Jae Hong SeoMedical Oncology Department, Korea University Guro Hospital, Seoul, South Korea.
Jin-Hee AhnDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Tae-Yong KimSeoul National University Hospital, Seoul, South Korea.
Seok Yun KangHematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
Joohyuk SohnDivision of Medical Oncology, Yonsei University, Seoul, South Korea.
Yaewon YangInternal Medicine, Chungbuk National University Hospital, Cheongju, South Korea.
Kyong Hwa ParkInternal Medicine, Korea University Anam Hospital, Seoul, South Korea.
Yong Wha MoonHematology and Oncology, CHA Bundang Medical Center, Seongnam, South Korea.
Seungtaek LimMedical Oncology Department, Wonju Severance Christian Hospital, Wonju, South Korea.
Myoung Joo KangHemato-Oncology, Inje University Haeundae Paik Hospital, Busan, South Korea.
Koung Eun YoonClinical Trial Team, Daehwa Pharmaceutical Co., Ltd., Seoul, South Korea.
Hyun Ju ChoClinical Trial Team, Daehwa Pharmaceutical Co., Ltd., Seoul, South Korea.
Keun Seok LeeCenter of Breast Cancer, National Cancer Center, Goyang, South Korea.
Dae Hwa Pharm (South Korea) · KRKorea University Medical Center · KRAjou University · KRAsan Medical Center · KRCHA University Bundang Medical Center · KRChungbuk National University Hospital · KRInje University Haeundae Paik Hospital · KRNational Cancer Center · KRSeoul National University Hospital · KRUlsan College · KRWonju Severance Christian Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStandard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer.

methodsThis multicenter, phase II study using a Simon's two-stage design investigated the efficacy and safety of DHP107 200 mg/m

resultsThirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34-81) and 11 (31%) had triple-negative disease. A median of seven cycles (range = 1-28) of DHP107 was administered. Objective response rate was 55% (17 patients), all partial responses, according to the investigator's decision and independent central review (ICR), and 44% (4/9 patients) in those with triple-negative disease. Disease control rate (partial response and stable disease) was 74% (23 patients) according to the investigator's decision and ICR. In the intention-to-treat (ITT) population of all enrolled participants, the objective response rate was 50% (18/36 patients). Median progression-free survival was 8.9 months [95% confidence interval [CI]: 5.2-12.3) and median time to treatment failure was 8.0 months (95% CI: 4.2-10.0). DHP107 had an acceptable toxicity profile. All patients experienced treatment-emergent adverse events; the most common adverse events were decreased neutrophil count (81% all grades and 78% grade ⩾ 3) followed by peripheral sensory neuropathy (61% all grades and 8% grade 3). However, there was no febrile neutropenia or sepsis.

conclusionDHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364).

trial registrationThis trial was registered with ClinicalTrials.gov identifier: NCT03315364.

Indexed as

DHP107first-lineHER2-negativemetastatic breast canceroral paclitaxel

Identifiers

PMID34925553
PMCPMC8679020
OpenAlexW4200064414

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.