Evidence map›Paper›PMID 23865786›Full record

Trial reportThe breast journal

Neo-adjuvant capecitabine chemotherapy in women with newly diagnosed locally advanced breast cancer in a resource-poor setting (Nigeria): efficacy and safety in a phase II feasibility study.

Olukayode A Arowolo, Uchenna O Njiaju, Temidayo O Ogundiran, Oyewale Abidoye, Olukayode O Lawal, Millicent Obajimi, Adebayo V Adetiloye, Hae K Im, Akinbolaji A Akinkuolie, Abideen Oluwasola and 10 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The breast journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. A systematic review and meta-analysis of side effects influenced by non-surgical treatments in African cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  2. Pooled it
  3. Innovative Strategies for Developing Biomarker-Informed Cancer Clinical Trials to Accelerate Progress in Precision Oncology in Sub-Saharan Africa.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2022
    Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. A Review on Breast Cancer Care in Africa.Breast care (Basel, Switzerland) · 2015
    Review
  12. Article
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  14. Article
  15. 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

20 authors.

Olukayode A ArowoloDepartment of Surgery, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Osun, Nigeria.
Uchenna O Njiaju
Temidayo O Ogundiran
Oyewale Abidoye
Olukayode O Lawal
Millicent Obajimi
Adebayo V Adetiloye
Hae K Im
Akinbolaji A Akinkuolie
Abideen Oluwasola
Kayode Adelusola
Adesunkanmi A Kayode
Augustine E Agbakwuru
Helen Oduntan
Chinedum P Babalola
Gini Fleming
Olusola C Olopade
Adeyinka Gladys Falusi
Muheez A Durosinmi
Olufunmilayo I Olopade

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
Variation in Hormone and xenobiotic metabolizing enzyme genes and breast cancerP50CA125183 · NCI · UNIVERSITY OF CHICAGO · PI COX, NANCY · 2006 to 2010
$11.3M
International Partnership for Interdisciplinary Research TrainingD43TW009112 · FIC · UNIVERSITY OF CHICAGO · PI OLOPADE, CHRISTOPHER O, OLOPADE, OLUFUNMILAYO F. · 2012 to 2016
$1.1M
FIC NIH HHS D43 TW009112NCI NIH HHS P30 CA014520NCI NIH HHS P50 CA125183
6 · The paper itself

Abstract

The majority of clinical trials of neo-adjuvant therapy for breast cancer have been conducted in resource-rich countries. We chose Nigeria, a resource-poor country, as the major site for a phase II feasibility open-label multicenter clinical trial designed to evaluate the efficacy, safety, and tolerability of neo-adjuvant capecitabine in locally advanced breast cancer (LABC). Planned treatment consisted of 24 weeks of capecitabine at a dose of 1,000 mg/m(2) twice daily (2,000 mg/m(2) total per day). The primary endpoints were overall, partial, complete clinical response rate (OCR, PCR, CCR) and complete pathologic response (cPR). A total of 16 patients were recruited from August 2007 to April 2010. The study was terminated early as a result of slow accrual. After the first three cycles of therapy, PCR were seen in five of 16 patients (31%; 95% CI 11-59%). Of the remaining 11 patients, eight had no response (NR) or stable disease (SD), and three had progressive disease (PD). Seven patients proceeded with further therapy of which had SD. OCR at the end of eight cycles was 44% (95% CI 20-70%). Clinical response and radiologic response by ultrasonomammography were highly concordant (spearman correlation 0.70). The most common adverse effect was Grade 1 hand-foot syndrome, which was seen in 75% of patients. Despite several limitations, we successfully carried out this phase II feasibility study of neo-adjuvant capecitabine for LABC in Nigeria. Capecitabine monotherapy showed good overall response rates with minimal toxicity and further studies are warranted.

Indexed as

Neoadjuvant TherapyAdultAgedAntimetabolites, AntineoplasticBreast NeoplasmsCapecitabineDeoxycytidineFeasibility StudiesFemaleFluorouracilHumansMiddle AgedNigeriaAntimetabolites, AntineoplasticCapecitabineDeoxycytidineFluorouracilcapecitabineclinical responselocally advanced breast cancerNigeriaresource-poor country

Identifiers

PMID23865786
PMCPMC4282544

What OpenQuestion holds

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Registered trials

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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.