Recommandations francophones pour la pratique clinique concernant la prise en charge des cancers du sein de Saint-Paul-de-Vence 2022-2023.

With more than 60,000 new cases of breast cancer in mainland France in 2023 and 8% of all cancer deaths, breast cancer is the leading cancer in women in terms of incidence and mortality. While the number of new cases has almost doubled in 30 years, the percentage of patients at all stages alive at 5 years (87%) and 10 years (76%) testifies to the major progress made in terms of screening, characterisation and treatment. However, this progress, rapid as it is, needs to be evaluated and integrated into an overall strategy, taking into account the characteristics of the disease (stage and biology), as well as those of the patients being treated. These are the objectives of the St Paul-de-Vence recommendations for clinical practice. We report here the summary of the votes, discussions and conclusions of the Saint-Paul-de-Vence 2022-2023 RPCs.

Fertility preservation, contraception and menopause hormone therapy in women treated for rare ovarian tumours: guidelines from the French national network dedicated to rare gynaecological cancers.

INTRODUCTION: Rare ovarian tumours include complex borderline ovarian tumours, sex-cord tumours, germ cell tumours and rare epithelial tumours. Indications and modalities of fertility preservation (FP), infertility management, contraindications for hormonal contraception or menopause hormone therapy are frequent issues in clinical practice. A panel of experts from the French national network dedicated to rare gynaecological cancers, and experts in reproductive medicine and gynaecology have built guidelines on FP, contraception and menopause hormone therapy in women treated for ovarian rare tumours. MATERIAL AND METHODS: A panel of 35 experts from different specialties contributed to the preparation of the guidelines, following the DELPHI method (formal consensus method). Statements were drafted after a systematic literature review and then rated through two successive rounds. RESULTS: Thirty-five recommendations were identified, concerning indications for FP, contraindications for ovarian stimulation, contraceptive options and menopause hormone therapy for each tumour type. DISCUSSION: Overall, caution has been recommended in the case of potentially hormone-sensitive tumours such as sex-cord tumours, serous and endometrioid low-grade adenocarcinomas, as well as for high-risk serous borderline ovarian tumours. CONCLUSION: In the context of a scarce literature, a formal consensus method allowed the elaboration of guidelines, which will help clinicians in the management of these patients.

[Fertility preservation, contraception and menopause hormone therapy in women treated for rare ovarian tumors: Guidelines from the French national network dedicated to rare gynaecological cancer]. / Préservation de la fertilité, contraception et traitement hormonal de la ménopause chez les femmes traitées pour tumeurs malignes rares de l'ovaire : recommandations du réseau national dédié aux cancers gynécologiques rares (TMRG/GINECO).

INTRODUCTION: Rare ovarian tumors include complex borderline ovarian tumors, sex-cord tumors, germ cell tumors, and rare epithelial tumors. Indications and modalities of fertility preservation, infertility management and contraindications for hormonal contraception or menopause hormone therapy are frequent issues in clinical practice. A panel of experts from the French national network dedicated to rare gynaecological cancers, and of experts in reproductive medicine and gynaecology have worked on guidelines about fertility preservation, contraception and menopause hormone therapy in women treated for ovarian rare tumors. METHODS: A panel of 39 experts from different specialties contributed to the preparation of the guidelines, following the DELPHI method (formal consensus method). Statements were drafted after a systematic literature review, and then rated through two successive rounds. RESULTS: Thirty-five recommendations were selected, and concerned indications for fertility preservation, contraindications for ovarian stimulation (in the context of fertility preservation or for infertility management), contraceptive options (especially hormonal ones), and menopause hormone therapy for each tumor type. Overall, prudence has been recommended in the case of potentially hormone-sensitive tumors such as sex cord tumors, serous and endometrioid low-grade adenocarcinomas, as well as for high-risk serous borderline ovarian tumors. DISCUSSION: In the context of a scarce literature, a formal consensus method allowed the elaboration of guidelines, which will help clinicians in the management of these patients.

Mise à jour 2016 des recommandations pour la pratique clinique de Nice/Saint-Paul-de-Vence dans le cancer de l'ovaire et du col de l'utérus à un stade avancé.

UPDATED 2016 RECOMMENDATIONS FOR THE CLINICAL PRACTICE OF NICE/SAINT-PAUL-DE-VENCE IN OVARIAN CANCER AND ADVANCED CERVICAL CANCER: Since the first edition of the 2012-2013 Clinical Practice Recommendations Nice-Saint-Paul for gynecological cancers, the management of ovarian cancer has become more complex with a better definition of histological subtypes of ovarian cancers, the update of the anatomo-clinical classifications, the evolution of the recommended quality criteria for surgery. In addition, the integration of new medical options, such as PARP inhibitors, requires us to review our management of ovarian cnacer patients (including early systematic oncogenetic research of homologous recombination pathway deficiency). Similarly, medical treatment has evolved in advanced cervical cancer with the new option of bévacizumab therapy. On behalf of the GINECO group, we have updated the guidelines for ovarian epithelial cancer (excepted rare tumors) and advanced cervical cancer in order to allow rapid dissemination of the latest advances to the medical community in order to adjust the daily practice.

Supportive Care Organization in France: a national in-depth survey among patients and oncologists.

PURPOSE: Medical doctors' (MDs), but not patients', perception of supportive care in cancer (SCC) in France has been previously assessed in a national survey. This study evaluated MDs and patients' perceptions of the SCC organization and implementation in France. METHODS: The French SCC Association conducted two observational studies: study 1 (S1), containing a 30-point questionnaire sent to 2263 MDs, and study 2 (S2), containing a 40-point questionnaire sent to 2000 patients. RESULTS: Overall, 711 MDs completed S1 and 1562 patients completed S2. In S1, 81% of MDs reported relying on a SCC organization and 76% attended SCC multidisciplinary discussions. MDs considered palliative (98%), psychological (98%), and social care (98%) as the top 3 SCC areas of importance for patients. In contrast, patients' priorities were psychology (61%), nutrition (55%) and organization of intake consultations (55%). The concept of SCC was familiar to 34% of patients; according to MDs, this concept was introduced mainly by MDs (78%) and admission nurses (41%). Outpatients identified as professional resources for SCC information general practitioners (84%), nurses (58%), and pharmacists (52%). Patients reported supportive treatment being prescribed in 63% of cases, with 64% receiving information on the negative side-effects. Among MDs, 87% reported proposing palliative and 41% adjuvant SCC treatment. Furthermore, 72% of MDs recommended SCC treatment at the metastatic stage, and 36% immediately following diagnosis. DISCUSSION: Oncologists play a vital role in enhancing SCC efficacy. This can be increased by implementing a multidisciplinary integrated approach or by assuring the availability of patient information.

[Perception of pT1a,b pN0 breast tumor prognosis by the French oncology community: Results of the EURISTIC national survey]. / Perception du pronostic des tumeurs mammaires pT1a,b pN0 par la communauté oncologique française : résultats de l'enquête nationale EURISTIC.

The prognosis of infracentimetric breast cancers (BC) is heterogeneous. The EURISTIC survey describes how French oncology specialists perceive the prognosis of pT1a,b pN0 BCs. A self-administered questionnaire has been sent to over 2000 French BC specialists. Six hundred and sixty-three physicians responded. Fifty-eight percent do not consider tumor size as a key prognostic criterion. They consider that the cutoff for poor prognosis is 22mm, 10mm and 7mm for hormone receptors (HRs)+, HER2+ and triple-negative (TN) tumors respectively. Eighty-three percent of respondents consider that a HR+ pT1a,b tumor has a good prognosis (21% and 8% for HER2+ and TN respectively). Factors perceived as most detrimental are: HER2 overexpression (29% of respondents); HR- (20%); high grade (20%); TN status (14%); high KI67 (5%); presence of lymphovascular invasion (3%); young age (2%) and high mitotic index (1%). For French specialists, immunohistochemical characteristics, in particular hormone and HER2 status, are strong prognostic factors in BCs below 1cm.

[Use of guidelines and heterogeneity of decision making for adjuvant chemotherapy in hormone-receptor positive, HER2-negative, early breast cancer: results of a French national survey]. / Utilisation de référentiels et hétérogénéité décisionnelle des indications de chimiothérapie adjuvante dans les cancers du sein exprimant les récepteurs hormonaux, HER2-négatifs : résultats d'un sondage national en France.

Adjuvant chemotherapy for localised breast cancer aims at reducing the risk of relapse and at increasing overall survival. Decision criteria include tumour burden and biological profile. It appears currently difficult to evaluate the benefit/risk ratio in certain borderline cases, which are more and more frequent. We have evaluated through an anonymous web survey conducted as part of the 2013 Annual Saint-Paul-de-Vence breast conference, the chemotherapy decisions, use of guidelines and level of certainty with decisions in this type of situation through four clinical cases. The survey was proposed to 1,190 French physicians who are directly in charge of breast cancer care, whatever their specialty. Three hundred and fifty-three of them replied, of whom 67 % were oncologists and 15 % surgeons. A significantly heterogeneous decision was observed for two out of four cases, in which 52 and 69 % of the physicians opted for adjuvant chemotherapy, versus 48 and 21 % for abstention respectively. Eighty seven percent of responding physicians used guidelines to guide their decision. These guidelines were regional for 63 %, national for 36 %, local in 21 % and international in 16 % of the cases. The level of certainty varied with clinical cases but not with the physician's specialty, nor type of decision.

[Node negative breast cancer. Beyond international consensus: a pragmatic approach]. / Le cancer du sein sans envahissement ganglionnaire. Au-delà des consensus internationaux: une approche pragmatique.

Apart from therapeutic advances related to new treatments, our practices in the management of early breast cancer have been modified by to key organizational settings (1) mass screening, substantially altering the presentation and epidemiology of breast cancer and (2) the development of guidelines to ensure that any patient management is in agreement with the demonstrated impact in the adjuvant treatment. In daily practice, the impact of screening and guidelines recommendations has put us now in a paradoxical situation: while the majority of non-metastatic breast cancers treated in the hexagon are node negative, most of the results of clinical studies on chemotherapy and targeted therapies today arise from populations predominantly node positive. Therefore, it seemed legitimate to convene a working group around a reflection on the directions of adjuvant chemotherapy in a growing node negative population in order to better respond to the questions of the field oncologists, trying to address the discrepancies between different existing guidelines.

Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study.

BACKGROUND: The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP). PATIENTS AND METHODS: The study observed 623 patients for > or = 2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for > or = 30 days following progression or stopped at or before progression. RESULTS: The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months). CONCLUSION: The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.

Prognostic role of pregnancy occurring before or after treatment of early breast cancer patients aged <35 years: a GET(N)A Working Group analysis.

BACKGROUND: Usual practices recommend waiting at least 2 years between diagnosis of early breast cancer (EBC) and pregnancy. Few data highlighted a harmful effect of an early pregnancy for low-risk patients. The authors analyzed retrospectively data from women younger than 35 years who became pregnant before or after treatment of EBC. METHODS: Between 1990 and 1999, 908 consecutive EBC patients were analyzed. The primary endpoint was to compare overall survival (OS) between pregnant and nonpregnant patients. The secondary endpoint was to establish a score index laying down the risk of distant recurrence. RESULTS: Within the year before the diagnosis, 105 (11.6%) patients became pregnant and 118 (13%) were pregnant after treatment. In a multivariate model, a pregnancy before the diagnosis was not predictive of death but of local relapse. A pregnancy subsequent to breast cancer therapy resulted in a 77% decrease of death (P < .001). In good-prognosis score index patients, the annual risk of relapse remained low. In patients having the higher score, recurrences occurred mainly during the first years after the treatment. Beyond 80 months, the annual risk of relapse seemed to be similar to those of lower-risk subgroups. CONCLUSIONS: In women aged younger than 35 years, a pregnancy occurring before or after the diagnosis of breast cancer was not an independent prognostic factor of death. In the subset of patients having a high risk of relapse, it may be preferable to postpone a pregnancy beyond 5 years after the breast cancer therapy.

Physiopathology and management of osteonecrosis of the jaws related to bisphosphonate therapy for malignant bone lesions. A French expert panel analysis.

Bisphosphonates (BP) are the current standard of care for preventing malignant skeletal related-events. Recent reports have documented the relationship between osteonecrosis of the jaws (ONJ) and the use of BPs. Based on the opinion of experts, the purpose of our analysis was to summarize current knowledge, to propose therapeutic options, and to define areas of research. Identified risk factors were long-lasting exposure to BPs, intravenous nitrogen-containing BPs, and poor dental status. Three major hypotheses could explain the genesis of ONJ: excess of bone turnover inhibition, antiangiogenic effect, and local infection. Before the onset of therapy, the dental status must be controlled, and followed during treatment. Dental procedures could worsen the risk of ONJ, and indications must be well evaluated. When an ONJ occurs, the management should be adapted according to its extent. Thereby, a customization of BP therapy should be applied taking into account the aggressiveness of the underlying disease.

[The use of deodorants/antiperspirants does not constitute a risk factor for breast cancer]. / L'utilisation de déodorants/antitranspirants ne constitue pas un risque de cancer du sein.

Based on the observation of a high incidence of breast cancer in the upper outer quadrant adjacent to the usual area of application of deodorants and/or antiperspirants, several scientific teams have advanced the hypothesis of a possible link between antiperspirants and breast cancer. The possibility of the involvement of parabens and aluminium salts, traditional components of a number of cosmetic products, has been advanced by the same teams. In order to ascertain whether this hypothesis could or could not be confirmed, a group of clinical experts in oncology was set up to search and analyse the literature data relating to the problem raised with the aim of answering three predefined questions: 1) does it exist experimental or biological arguments supporting a potential link between the use of deodorants/antiperspirants and breast cancer? 2) Does the use of deodorants/antiperspirants have any effect on the increase in the risk of breast cancer? 3) Could a causal relationship between the use of deodorants/antiperspirants and breast cancer be accepted? The scientific data were searched systematically in the PubMed database (http://www.ncbi.nlm.nih.gov/sites/entrez) using standardised search equations. Fifty-nine studies resulting from the literature search were reviewed and nineteen articles with various methodologies were selected for in-depth analysis. In view of the fact that parabens are generally not present in deodorants/antiperspirants, the reflection group's search related purely to the question of aluminium salts. Among these nineteen articles, many are methodologically unsound, do not answer to the questions posed or deal with the question of parabens and were therefore discarded by the reflection group. The expert group's conclusion coincides with those of the French, European and American health authorities. After analysis of the available literature on the subject, no scientific evidence to support the hypothesis was identified and no validated hypothesis appears likely to open the way to interesting avenues of research.

Impact of organised programs on colorectal cancer screening.

PURPOSE: Colorectal cancer (CRC) screening has been shown to decrease CRC mortality. Organised mass screening programs are being implemented in France. Its perception in the general population and by general practitioners is not well known. METHODS: Two nationwide observational telephone surveys were conducted in early 2005. First among a representative sample of subjects living in France and aged between 50 and 74 years that covered both geographical departments with and without implemented screening services. Second among General Practionners (Gps). Descriptive and multiple logistic regression was carried out. RESULTS: Twenty-five percent of the persons(N = 1509) reported having undergone at least one CRC screening, 18% of the 600 interviewed GPs reported recommending a screening test for CRC systematically to their patients aged 50-74 years. The odds ratio (OR) of having undergone a screening test using FOBT was 3.91 (95% CI: 2.49-6.16) for those living in organised departments (referent group living in departments without organised screening), almost twice as high as impact educational level (OR = 2.03; 95% CI: 1.19-3.47). CONCLUSION: CRC screening is improved in geographical departments where it is organised by health authorities. In France, an organised screening programs decrease inequalities for CRC screening.

Cancer screening in France: subjects' and physicians' attitudes.

OBJECTIVE: Since screening for cancer has been advocated, funded, and promoted in France, it is important to evaluate the attitudes of subjects in the general population and general practitioners (GPs) toward cancer screening strategies. METHODS: EDIFICE is a nationwide opinion poll that was carried out by telephone among a representative sample of 1,504 subjects living in France and aged between 40 and 75 years and among a representative sample of 600 GPs. The questionnaire administered to subjects queried about previous screening for cancer. RESULTS: Ninety-three percent of women stated that they had undergone at least one mammography. Although rated "A" recommendation-strongly recommended-by the US Preventive Services Task Force, screening for colorectal cancer received less attention than prostate cancer screening which is rated "I"-insufficient evidence-(reported screening rates of 25% and 36%, respectively). Six percent of subjects stated that they had undergone lung cancer screening. GPs' attitudes toward cancer screening showed similar inconsistencies. CONCLUSIONS: It thus appears that understanding of cancer screening practices in the French general population does not match scientific evidence. To a lesser extent, this also holds for GPs.

[Updates on gemcitabine on metastatic breast cancer]. / Actualités de la gemcitabine dans le cancer du sein métastatique.

Gemcitabine is one of the key products actually used in metastatic breast cancer. Thanks to its favourable toxicity profile, gemcitabine can be used in combination with a number of drugs. Recently published and presented results from different trials may modify our perception and strategies regarding metastatic breast cancer. In this overview we will focus on the results of these trials and particularly those recent concerning the combination of gemcitabine with taxanes, vinorelbine, platinum salts and trastuzumab.

Novel therapeutic strategies combining antihormonal and biological targeted therapies in breast cancer: focus on clinical trials and perspectives.

Several models have been proposed to explain the mechanisms of endocrine resistance including aberrant growth-signaling pathways, and have led to the rational design of studies combining hormonotherapy with signal transduction inhibitors (STI) in advanced breast cancer. This article reviews the current status of these clinical trials. Preliminary results from the randomized controlled trials are rather disappointing. The mTOR inhibitor temsirolimus and the farnesyl transferase inhibitor tipifarnib combined with letrozole did not show any benefit compared to letrozole alone. As neoadjuvant therapy, gefinitib did not enhance the response rate induced by anastrozole. Interesting results were obtained with exemestane combined to celecoxib but should be further explored with adequate cardiac monitoring. Trastuzumab combined with anastrozole was more effective than anastrozole in terms of response rate and progression-free survival but not survival. Several controlled trials as first- or second-line therapy have started recently and over the next few years we should learn whether this approach will provide significant gains in efficacy.

Multicenter phase II trial of neoadjuvant therapy with trastuzumab, docetaxel, and carboplatin for human epidermal growth factor receptor-2-overexpressing stage II or III breast cancer: results of the GETN(A)-1 trial.

PURPOSE: Trastuzumab plus chemotherapy has become the standard of care for human epidermal growth factor receptor-2 (HER-2) -positive breast cancer. Trastuzumab-based preoperative systemic therapy (PST; neoadjuvant therapy) also appears promising, warranting further investigation. PATIENTS AND METHODS: Patients with HER-2-positive, stage II/III, noninflammatory, operable breast cancer requiring a mastectomy (but who wanted to conserve the breast) received trastuzumab 4 mg/kg (day 1), followed by 2 mg/kg weekly, plus docetaxel 75 mg/m2 every 3 weeks, and carboplatin (area under curve, 6) for six cycles before surgery. The primary end point was pathologic complete response (pCR) rate, determined from surgical specimens. RESULTS: Seventy patients were enrolled. Most patients had clinical T2/T3 tumors (100%) or clinical N1/2 nodes (53%). Sixty-seven patients (96%) completed six cycles of therapy, one patient withdrew due to progressive disease, and two patients withdrew for toxicity. A complete or partial objective clinical response occurred in 95% of patients (85% and 10%, respectively). Surgery was breast conservative in 45 (64%) of 70 patients. In an intent-to-treat analysis, tumor and nodal pCR were seen in 27 (39%) of 70 patients. Centralized retrospective analysis of HER-2 status demonstrated a 43% pCR rate in the 24 of 56 confirmed HER-2-overexpressing (3+) and/or fluorescence in situ hybridization-positive tumors. Treatment was generally well tolerated. Grade 3/4 neutropenia and febrile neutropenia were uncommon (2%). Two patients withdrew prematurely due to a transient, asymptomatic decrease in left ventricular ejection fraction. No symptomatic cardiac dysfunction occurred. CONCLUSION: PST with trastuzumab plus docetaxel and carboplatin achieved promising efficacy, with a good pCR rate and favorable tolerability in stage II or III HER-2-positive breast cancer.

Epirubicin-based chemotherapy as adjuvant treatment for poor prognosis, node-negative breast cancer: 10-year follow-up results of the French Adjuvant Study Group 03 trial.

We evaluated the contribution of an epirubicin-based adjuvant chemotherapy on disease-free survival (DFS) in poor prognosis, node-negative breast cancer (BC) patients. Poor prognostic factors were defined as: pathologic tumor size >or= 4 cm, estrogen-receptor negative, and progesterone-receptor negative. Scarff-Bloom Richardson grade 2 tumors must have two of these factors, and only one in case of grade 3. Between 1988 and 1994, 328 patients were randomized to receive either no systemic treatment (control, n = 161), or fluorouracil 500 mg/m(2), epirubicin 50 mg/m(2), cyclophosphamide 500 mg/m(2), 6 cycles every 21 days (FEC50, n = 167), without any hormonal treatment. The median follow up was 114 months. The 10-year DFS rates were 64 and 71%, respectively (p = 0.23). In the Cox regression model, independent prognostic factors of relapse were the number of nodes examined < 10 (p = 0.002), BCS (p = 0.01), and premenopausal status (p = 0.04). In this model, the relative risk of relapse was 1.46 (CI95 %: 1.05-1.87) in favor of FEC50. In patients who underwent BCS, 21 % developed a local relapse (24 versus 18 %, respectively). The 10-year local DFS was 70.5 and 79.3 %, respectively (p = 0.27). The 10-year overall survival was not different (74.1 versus 70.7 %, p = 0.82). After 10 years of follow-up, the FEC50 regimen reduced the risk of relapse in poor-prognosis node-negative BC patients. The incidence of local relapse was high, and probably related to inclusion criteria. Epirubicin was probably underdosed in such patients, and ongoing studies using 100 mg/m(2) of epirubicin will give us the answer in a near future.

Pharmacogenetics of capecitabine in advanced breast cancer patients.

PURPOSE: Germinal gene polymorphisms can explain a part of the interpatient pharmacodynamic variability of anticancer drugs, particularly fluoropyrimidines. Genes for which polymorphisms may potentially influence pharmacodynamics of fluoropyrimidines, including capecitabine, are thymidylate synthase (TS), methylenetetrahydrofolate reductase (MTHFR), and dihydropyrimidine dehydrogenase (DPD). EXPERIMENTAL DESIGN: The aim of this prospective pilot study was to analyze the effect of TS, MTHFR, and DPD gene polymorphisms on toxicity and efficacy in advanced breast cancer patients receiving capecitabine as monotherapy. Germinal polymorphisms of TS (6 bp deletion in the 3' region and 28 bp repeats, including G>C mutation in the 5' region), MTHFR (677C>T and 1298A>C), and DPD (IVS14+1G>A) were determined in 105 consecutive patients. RESULTS: A trend toward a higher global toxicity grade 3 and 4 was observed in patients homozygous for the TS 3RG allele compared with patients heterozygous for the 3RG allele or patients not carrying the 3RG allele (50% versus 19% versus 13% respectively, P=0.064). The sole patient bearing the DPD IVS14+1G>A mutation (heterozygous) deceased from hematologic toxicity. The median response duration was 5.8 months (95% confidence interval, 4.3-7.2). Duration of response was significantly shortened in patients homozygous for the 3RG allele compared with others (P=0.037). CONCLUSIONS: The present data suggest that 3RG3RG breast cancer patients are not good candidates for capecitabine therapy. In addition, attention should be paid to DPD deficiency in breast cancer patients receiving capecitabine. These preliminary data require further confirmation on a larger number of patients.