Cancer Society Clinical Practice Guideline Research Articles

Treatment patterns and clinical outcomes in patients with metastatic triple-negative breast cancer: a large-scale data analysis using the Japanese claims database.

This study evaluated treatment patterns and clinical outcomes among patients with metastatic triple-negative breast cancer (mTNBC) in real-world clinical settings in Japan. The treatment patterns, time to next treatment or death (TTNTD), time to treatment discontinuation, adverse events of interest, and medical costs of treating patients with mTNBC in first-, second-, and third-line settings were investigated using data of patients meeting the inclusion criteria between January 2017 and March 2022 in a Japanese medical claims database. The treatment regimens for mTNBC were defined according to the Japanese Breast Cancer Society Clinical Practice Guidelines. In this study, 2236 patients with mTNBC (median age 66.0years; 99.8% female) were included in the first-line cohort. Of these, 46.6% and 20.8% were included in the second- and third-line cohorts, respectively. The two most frequently used treatments were capecitabine (19.1%) and S-1 (tegafur-gimeracil-oteracil) (14.5%) in the first-line cohort, eribulin (18.3%) and bevacizumab/paclitaxel (14.4%) in the second-line cohort, and eribulin (19.4%) and bevacizumab/paclitaxel (17.5%) in the third-line cohort. The TTNTD shortened as the line of therapy progressed (median 8.0, 6.5, and 5.2months for the first-, second-, and third-line treatments, respectively). Nausea/vomiting and neutropenia/leukopenia occurred in 62.8% and 18.3% of all patients, respectively. The medical total costs per day were 6.7, 10.2, and 12.9 thousand yen during the first-/second-/third-line treatments, respectively. This study provides insight into current treatment patterns for mTNBC in Japan. The cost-benefit balance worsens with later-line treatment and a high unmet need for mTNBC drug treatment remains.

The Japanese breast cancer society clinical practice guidelines for radiation treatment of breast cancer, 2022 edition.

The Breast Cancer Clinical Practice Guidelines, organized by the Japanese Breast Cancer Society (JBCS), were published in 2022. We present the English version of the Radiation Therapy (RT) section of the guidelines. The JBCS formed a task force to update the 2018 version of the JBCS Clinical Practice Guidelines. The Background Questions (BQs) contain the standard treatments for breast cancer in clinical practice, whereas the Clinical Questions (CQs) address daily clinical questions that remain controversial. Future Research Questions (FRQs) explore the subjects that are considered important issues, despite there being insufficient data for inclusion as CQs. The task force selected the 12 BQs, 8 CQs, and 6 FRQs for the RT section. For each CQ, systematic literature reviews and meta-analyses were conducted according to the Minds Manual for Guideline Development 2020, version 3.0. The recommendations, strength of recommendation, and strength of evidence for each CQ were determined based on systematic reviews and meta-analyses, and finalized by voting at the recommendation decision meeting.

The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer, 2022 Edition: changes from the 2018 edition and general statements on breast cancer treatment

The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer, 2022 Edition was published in June 2022. The guidelines were prepared while conforming as much as possible to the “Minds Manual for Guideline Development 2020 ver. 3.0.” edited by the Minds Manual Development Committee of the Japan Council for Quality Health Care in 2021. In addition, a survey of Japanese Breast Cancer Society members on the 2018 edition of the guidelines was conducted from February 19 to March 4, 2021. Based on the responses from over 600 members, original innovations were made to make the guidelines more user-friendly. The 2018 edition of the guidelines was developed to provide support tools for physicians and patients to utilize shared decision-making. The 2022 guidelines consist of two volumes: (1) an “Epidemiology and Diagnosis” section covering “Screening and Diagnosis”, “Radiological diagnosis”, and “Pathological diagnosis”, and (2) a “Treatment” section covering “Surgical therapy”, “Radiation therapy”, and “Systemic therapy”. We believe that this concise summary of the guidelines will be useful to physicians and researchers in Japan and overseas.

Trastuzumab deruxtecan for human epidermal growth factor receptor 2-low advanced or metastatic breast cancer: recommendations from the Japanese Breast Cancer Society Clinical Practice Guidelines

The Japanese Breast Cancer Society Clinical Practice Guidelines are published as timely guidance on clinical issues in breast cancer treatment in Japan. In the recent edition of these guidelines, we addressed a new clinical question 34 (CQ 34, systemic treatment part) “Is trastuzumab deruxtecan recommended for patients with unresectable or metastatic HER2-low breast cancer?” and a new future research question 7 (FRQ 7, pathological diagnosis part) “How is HER2-low breast cancer diagnosed for the indication of trastuzumab deruxtecan?”. These questions address use of trastuzumab deruxtecan in patients with unresectable or metastatic HER2-low breast cancer who have previously received chemotherapy for metastatic disease. The strengths of evidence and recommendation were determined through a quantitative and qualitative systematic review using multiple outcomes, including efficacy and safety. We conclude that trastuzumab deruxtecan is recommended for this patient population (strength of recommendation: 1; strength of evidence: moderate; CQ34) and that HER2-low expression for the indication of trastuzumab deruxtecan should be diagnosed using companion diagnostics based on appropriate criteria (FRQ7).

The Japanese Breast Cancer Society clinical practice guidelines for epidemiology and prevention of breast cancer, 2022 edition

The Japanese Breast Cancer Society Clinical Practice Guidelines for Epidemiology and Prevention of Breast Cancer, 2022 Edition.

The Japanese breast cancer society clinical practice guidelines for breast cancer screening and diagnosis, 2022 edition

This article provides updates to readers based on the newly published Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis, 2022 Edition. These guidelines incorporate the latest evaluation of evidence from studies of diagnostic accuracy. For each clinical question, outcomes for benefits and harms were established, and qualitative or quantitative systematic reviews were conducted. Recommendations were determined through voting by a multidisciplinary group, and guidelines were documented to facilitate shared decision-making among patients and medical professionals. The guidelines address screening, surveillance, and pre- and postoperative diagnosis of breast cancer. In an environment that demands an integrated approach, decisions are needed on how to utilize modalities, such as mammography, ultrasound, MRI, and PET/CT. Additionally, it is vital to understand the appropriate use of new technologies, such as tomosynthesis, elastography, and contrast-enhanced ultrasound, and to consider how best to adapt these methods for individual patients.

The Japanese breast cancer society clinical practice guidelines for pathological diagnosis of breast cancer, 2022 edition.

The Japanese breast cancer society clinical practice guidelines for pathological diagnosis of breast cancer, 2022 edition.

The Japanese Breast Cancer Society Clinical Practice Guidelines for surgical treatment of breast cancer, 2022 edition.

The 2022 revision of the Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for surgical treatment of breast cancer was updated following a systematic review of the literature using the Medical Information Network Distribution Service (MINDS) procedure, which focuses on the balance of benefits and harms for various clinical questions (CQs). Experts in surgery designated by the JBCS addressed five areas: breast surgery, axillary surgery, breast reconstruction, surgical treatment for recurrent and metastatic breast cancer, and other related topics. The revision of the guidelines encompassed 4 CQs, 7 background questions (BQs), and 14 future research questions (FRQs). A significant revision in the 2022 edition pertained to axillary management after neoadjuvant chemotherapy in CQ2. The primary aim of the 2022 JBCS Clinical Practice Guidelines is to provide evidence-based recommendations to empower patients and healthcare professionals in making informed decisions regarding surgical treatment for breast cancer.

The Japanese Breast Cancer Society Clinical Practice Guidelines for systemic treatment of breast cancer, 2022 edition

The Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for systemic treatment of breast cancer were updated to the 2022 edition through a process started in 2018. The updated guidelines consist of 12 background questions (BQs), 33 clinical questions (CQs), and 20 future research questions (FRQs). Multiple outcomes including efficacy and safety were selected in each CQ, and then quantitative and qualitative systematic reviews were conducted to determine the strength of evidence and strength of recommendation, which was finally determined through a voting process among designated committee members. Here, we describe eight selected CQs as important updates from the previous guidelines, including novel practice-changing updates, and recommendations based on evidence that has emerged specifically from Japanese clinical trials.

Alcohol consumption and breast cancer prognosis after breast cancer diagnosis: a systematic review and meta‑analysis of the Japanese Breast Cancer Society Clinical Practice Guideline, 2022 edition

Alcohol consumption is internationally recognized as one of the compelling risk factors for breast cancer, but it does not necessarily correlate with the prognosis of breast cancer patients. Alcohol consumption in breast cancer patients was addressed in the 2022 Breast Cancer Clinical Practice Guidelines. A systematic review and meta-analysis of epidemiological studies on alcohol consumption and breast cancer recurrence, breast cancer-related mortality, all-cause mortality, and cardiovascular disease mortality in breast cancer patients was performed. The PubMed, Cochrane Library, and Ichushi-Web databases were searched for relevant publications reporting cohort or case–control studies published until March 2021. A total of 33 studies (32 cohort studies and 1 case–control study) met the eligibility criteria; 4638 cases of recurrence, 12,209 cases of breast cancer-specific mortality, and 21,945 cases of all-cause mortality were observed. With regard to breast cancer recurrence, 7 studies assessed pre-diagnosis alcohol consumption (relative risk (RR) 1.02, 95% confidence interval (95% CI) 0.77–1.37, p = 0.88) and 3 studies assessed post-diagnosis alcohol consumption (RR 0.96, 95% CI 0.85–1.10, p = 0.57), and no significant increase or decrease in risk was observed. With regard to breast cancer-related mortality, 19 studies assessed pre-diagnosis alcohol consumption (RR 1.02, 95% CI 0.93–1.11, p = 0.69), 9 studies assessed post-diagnosis alcohol consumption (RR 0.96, 95% CI 0.77–1.19, p = 0.70), and no significant increase or decrease in risk was observed. With regard to all-cause mortality, 18 studies assessed pre-diagnosis alcohol consumption (RR 0.90, 95% CI 0.82–0.99, p = 0.02), 8 studies assessed post-diagnosis alcohol consumption (RR 0.88, 95% CI 0.74–1.02, p = 0.08), and pre-diagnosis alcohol consumption was associated with a significantly decreased risk. With regard to cardiovascular disease mortality and alcohol consumption, 2 studies assessed it, and the RRwas 0.47 (95% CI 0.28–0.79, p = 0.005), showing that alcohol consumption was associated with a significantly decreased risk. The limitations of this study are that drinking status was mainly based on a questionnaire survey, which is somewhat inaccurate and has many confounding factors, and the cut-off value for the maximum alcohol intake in many studies was low, and it is possible that the actual intake was only an appropriate amount. In many countries, a standard drinking amount is set, and wise decisions are required.

The Japanese Breast Cancer Society Clinical Practice Guidelines for systemic treatment of breast cancer, 2018 edition

PurposeWe present the English version of The Japanese Breast Cancer Society (JBCS) Clinical Practice Guidelines for systemic treatment of breast cancer, 2018 edition.MethodsThe JBCS formed a task force to update the JBCS Clinical Practice Guidelines, 2015 edition, according to Minds Handbook for Clinical Practice Guideline Development 2014. First, we set multiple outcomes for each clinical question (CQ). Next, quantitative or qualitative systematic review was conducted for each of the multiple outcomes, and the strength of recommendation for the CQ was taken into consideration during meetings, with the aim of finding a balance between benefit and harm. Finalized recommendations from each session were confirmed through discussion and voting at the recommendation decision meeting.ResultsThe recommendations, the strength of recommendation and the strength of evidence were determined based on systemic literature reviews and the meta-analyses for each CQ.ConclusionThe JBCS updated the Clinical Practice Guidelines for systemic treatment of breast cancer.

Dose-dense adjuvant chemotherapy: a systematic review and meta-analysis of the Japanese Breast Cancer Society Clinical Practice Guideline, 2018 edition.

Increasing the dose intensity of cytotoxic therapy by shortening the intervals between cycles may enhance efficacy. Dose-dense chemotherapy, which is adopted as adjuvant chemotherapy of high-risk breast cancer, is addressed in the Japanese Breast Cancer Society Clinical Practice Guideline for breast cancer, 2018 edition (in Japanese). To evaluate the benefits and safety of dose-dense adjuvant chemotherapy described in the guideline, we performed a systematic review and meta-analysis of data of randomized trials using the same drugs, doses, and numbers of cycles. The PubMed, Cochrane Library, and Ichushi-Web databases were searched for relevant publications reporting randomized trials published until November 2016. Overall survival (OS), disease-free survival (DFS), and toxicity were assessed. Three trials comprising 5190 patients were included. Compared with conventional chemotherapy, dose-dense chemotherapy lengthened OS (RR = 0.76; 95% CI = 0.64-0.90) and DFS (RR = 0.83; 95% CI = 0.75-0.92) and increased the risk of anemia (RR = 4.56; 95% CI = 2.01-10.34). We conclude that dose-dense chemotherapy can be highly recommended as adjuvant chemotherapy for patients with breast cancer with a high risk of recurrence risk and sufficient bone marrow function.

The Japanese Breast Cancer Society clinical practice guidelines for surgical treatment of breast cancer, 2018 edition

We have prepared the Japanese Breast Cancer Society clinical practice guidelines (CPGs) for surgical treatment of breast cancer, 2018 update after a systematic review (SR) of the literature based upon the Medical Information Network Distribution Service (Minds) procedure. The CPG committee for surgical treatment of breast cancer, composed of breast surgeons and plastic surgeons treating breast cancer, has developed the CPGs. Eight clinical questions (CQs) were selected and divided roughly into the following five categories: (1) breast surgery in initial therapy (CQs 1–3); (2) axillary surgery in initial therapy (CQs 4–5); (3) breast reconstruction in initial therapy (CQ 6); (4) surgical treatment for recurrent and metastatic breast cancer (CQs 7–8); and (5) others. Recommendations for these CQs were decided by the GRADE grid method. In addition, 4 outlines, 14 background questions (BQs), and 12 future research questions (FQs) were also selected. Statements for these BQs and FQs are provided. We developed the updated CPGs for surgical treatment of breast cancer, 2018, which include 8 CQs and recommendations. As a decision-making tool for the understanding and treatment of breast cancer, these guidelines will help surgical oncologists dealing with breast cancer, medical staff, and patients, along with their family members.

The Japanese Breast Cancer Society Clinical Practice Guidelines, 2018 edition: the tool for shared decision making between doctor and patient

The Breast Cancer Clinical Practice Guidelines, 2018 edition, written in Japanese and organized by the Japanese Breast Cancer Society, were published in Japanese in May 2018. The process of making these guidelines, as well as the content, was largely changed and compared with previous editions. The concept of these guidelines is to act as a support tool for shared decision making between doctor and patient. The procedure of creating the guidelines referred to Minds Handbook for Clinical Practice Guideline Development 2014. This guideline, written in Japanese, consists of two booklets: (1) the epidemiology and diagnosis booklet covering screening, radiological, and pathological diagnosis and (2) the treatment booklet covering surgical therapy, radiation therapy, and systemic therapy. This review article consists of five parts, including the history of the Breast Cancer Clinical Practice Guidelines, the concept, process, content, and recommendation grade. I believe this brief summary concerning the Breast Cancer Clinical Practice Guidelines 2018 edition in English will be helpful for both Japanese and foreign investigators.

The Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis, 2018 Edition

This article updates readers as to what is new in the Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis, 2018 Edition. Breast cancer screening issues are covered, including matters of breast density and possible supplemental modalities, along with appropriate pre-operative/follow-up diagnostic breast imaging tests. Up-to-date clinical practice guidelines for breast cancer screening and diagnosis should help to provide patients and clinicians with not only evidence-based breast imaging options, but also accurate and balanced information about the benefits and harms of intervention, which ultimately enables shared decision making about imaging test plans.

The Japanese Breast Cancer Society Clinical Practice Guideline for radiation treatment of breast cancer, 2018 edition

PurposeThe Japanese Breast Cancer Society (JBCS) Clinical Practice Guideline was revised in 2018. This article describes the revise points in the section on radiation therapy (RT).Methods and materialsThe JBCS formed task force to update the JBCS Clinical Practice Guideline 2015 edition. Background questions (BQs) deal with standard treatments of breast cancer in clinical practice. Clinical questions (CQs) highlight the important treatments in which controversy remains. The task force for RT section addressed the 10 BQs, the 10 CQs, and the 4 Future reseach questions (FQs). For each CQ, systematic literature reviews and meta-analyses were conducted, and recommendations, strength of recommendation and strength of evidence were determined according to the protocol in Morizane et al. (Minds Handbook for Clinical Practice Guideline Development, 2014).ResultsThe recommendations, the strength of recommendation and the strength of evidence were determined based on the systematic literature reviews and the meta-analyses for each CQ.ConclusionThe JBCS updated the Clinical Practice Guideline. RT represents a significant portion of the breast cancer treatment, and these recommendations regarding RT will be useful in individualized, shared decision making between physicians and patients.

Abstract P3-03-34: Sentinel lymph node biopsy is unnecessary in ductal carcinoma in situ patients diagnosed by biopsy

Abstract Background: Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer 2018 state that sentinel lymph node (SN) biopsy is unnecessary for patients treated with breast-conserving therapy (BCT) and with an expected final pathological diagnosis of ductal carcinoma in situ (DCIS). Regardless of whether they were diagnosed with DCIS by biopsy before surgery, 78% of patients currently undergo axial procedures in Japan because invasive lesions may be detected in surgical specimens. This study examined whether SN biopsy can be omitted in DCIS patients diagnosed by biopsy and which factors are associated with invasion. Methods: Patients who underwent definitive surgery for DCIS diagnosed by preoperative biopsy at our institution from May 2004 to January 2018 were investigated retrospectively. The factors associated with upstaging to invasive cancer from DCIS were examined with Fisher's exact test and the t-test. (Age, Tumor size, Operation (Mastectomy or BCT), Biopsy method (Core Needle Biopsy or Vaccume-Assisted Biopsy), Mammography (ditected or not-detected), Ultrasound (ditected or not-detected, mass or non-mass), Comedo, ER, PgR, HER2) Results: A total of 311 patients were enrolled in this study, of whom 277 (89.1%) underwent SN; six of these (2.2%) had SN metastasis. All six cases were upstaging to invasive cancer: five (1.8%) had micrometastasis and one had macrometastasis (0.4%). From a surgical viewpoint, SN metastasis were detected in 3/161 (1.9%) cases treated with mastectomy and 3/150 (2.4%) cases treated with BCT. Although all three cases treated with BCT had micrometastasis, one case treated with mastectomy had macrometastasis (the other two cases had micrometatastasis). A total of 80/311 cases (25.7%) upstaged to invasive cancer and the only predictor of invasion was tumor size on images (p=0.0002). We could not determine the effective cut-off for tumor size because the area under the receiver operating characteristic curve was 0.63<0.70. Tabule 1.Tumor size on images was the only predictor of invasion. Upstaging (N=80)DCIS (N=231)P valueTumor size: mm (95% Confidence Interval)47.5 (41.9-53.2)33.9 (30.5-37.3)0.0002 Conclusion: Tumor size was found to be the only predictor of invasion. Only 2.2% of DCIS patients had SN metastasis despite the fact that 25.7% patients were upstaged to invasive cancer. We conclude that SN biopsy is not necessary for DCIS patients diagnosed by biopsy. Citation Format: Uemoto Y, Kondo N, Wanifuchi-Endo Y, Hisada T, Nishikawa S, Katagiri Y, Kato H, Takahashi S, Toyama T. Sentinel lymph node biopsy is unnecessary in ductal carcinoma in situ patients diagnosed by biopsy [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P3-03-34.

Abstract P5-22-15: Hormone receptor status is a predictive factor for axillary lymph node recurrence after sentinel lymph node biopsy

Abstract Background Axillary staging is important for predicting prognosis, and for local control in early breast cancer. Sentinel lymph node biopsy (SLNB) is a widely accepted method to avoid unnecessary axillary lymph node dissection (ALND). Since the ACOSOG Z0011 trial was published, we have refrained from ALND for selected patients with positive SLNB results. However, some cases have shown regional lymph node recurrences after SLNB without axillary dissection. The purpose of this study is to identify risk factors for recurrences, to ensure a safe axillary surgery. Methods A retrospective review of 1011 patientswho underwent SLNB without ALND between June 2004 and March 2017 was performed. Since October 2012, we have not performed ALND in patients (a) with 1 or 2 positive sentinel lymph nodes (SLNs), (b) with positive SLNs that are unmatted or not gross extra nodal extension, (C) in whom clinical tumor size is <5 cm, and (d) who receive adjuvant endocrine therapy or chemotherapy and radiotherapy. Cases of mastectomy, lumpectomy with a positive margin and additional resection or boost radiotherapy, and bilateral cancer were included. SLNs were identified using technetium sulfur colloid and indigo carmine blue dye, and were bisected in parallel to the long axis of the nodes. The sections were stained with hematoxylin and eosin. Adjuvant systemic and/or radiation treatment was delivered as per the National Comprehensive Cancer Network and the Japanese Breast Cancer Society clinical practice guidelines and was based on the patients' pathological and clinical traits. Results Of the 1011 patients, 969 had negative and 42 had positive SLNs. The median age of patients was 59 years (range 21-88). The median invasive breast tumor size was 15 mm (range 0.05-85), with 1.9% tumors being pathological T3 lesions; 127 patients (12.3%) developed lymphatic vessel invasion. SLNs identification rate was 99.4%. The median number of SLNs removed per patient was 2 (range 1-7). After follow-up of a median 78.5 months, 10 patients (1.0%) had an axillary recurrence and all of them had negative SLN metastasis. The median time to axillary recurrence was 26 months (range 9-94). The hormone receptor (HR) status was significantly related to axillary recurrence (p=0.008). While triple negativity had a tendency to relate (p=0.06), human epidermal growth factor receptor 2 (HER2) status did not correlate with axillary recurrence (p=0.13). Tumor subtypes and axillary recurrence SLNB without ALND (n=1011)Axillary recurrenceP valueHR positive72650.009HR negative1615 HER2 positive12130.13HER2 negative7667 Triple Negative10030.06Not Triple Negative7877 DCIS1240 DCIS: Ductal carcinoma in situ Conclusions As reported previously, the axillary recurrence rate after SLNB was low. Our results show that HR negativity was a significant factor for axillary recurrence. Although the ACOSOG Z0011 trial criteria focused on ALNB positive cases, they do not mention the tumor subtypes. Our findings show that HR negative patients without ALND have to follow up carefully. Citation Format: Sekine C, Nakano S, Mibu A, Otsuka M, Oinuma T. Hormone receptor status is a predictive factor for axillary lymph node recurrence after sentinel lymph node biopsy [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-22-15.

The Japanese Breast Cancer Society clinical practice guidelines for screening and imaging diagnosis of breast cancer, 2015 edition.

The Japanese Breast Cancer Society clinical practice guidelines for screening and imaging diagnosis of breast cancer, 2015 edition.

The Japanese Breast Cancer Society clinical practice guideline for surgical treatment of breast cancer, 2015 edition.

The Japanese Breast Cancer Society clinical practice guideline for surgical treatment of breast cancer, 2015 edition.