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PURPOSE We report findings on quality of life (QoL) in the RESPECT trial, which compared adjuvant trastuzumab monotherapy with trastuzumab plus chemotherapy in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). PATIENTS AND METHODS Patients age 70-80 years with human epidermal growth factor receptor 2-positive surgically treated breast cancer were randomly assigned to receive trastuzumab (T) or trastuzumab plus chemotherapy (T + C). QoL was assessed using the Functional Assessment of Cancer Therapy-General (FACT-G), Philadelphia Geriatric Center Morale Scale, Hospital Anxiety and Depression Scale, Patient Neurotoxicity Questionnaire, and Tokyo Metropolitan Institute of Gerontology Index of Competence at baseline and after 2, 12, and 36 months. Comparisons were based on individual changes from baseline and were performed by Fisher’s test or mixed-model repeated-measures. RESULTS Among 275 patients in the parent study, 231 (84%) (average age: 74 years) were included in the analysis. At 2, 12, and 36 months, 198, 177, and 178 patients completed surveys, and the mean FACT-G scores at each survey point were 78.9, 80.4, 82.7, and 79.1 in group T and 79.5, 74.5, 78.4, and 78.5 in group T + C. Compared with group T + C, the proportion of patients showing QoL deterioration (≥ 5 points decrease from baseline in FACT-G) was significantly lower at 2 months (31% v 48%; P = .016) and 12 months (19% v 38%; P = .009). In group T, the Hospital Anxiety and Depression Scale score ( P = .003) and the proportion of severe sensory peripheral neuropathy ( P = .001) were significantly lower at 2 months, and Philadelphia Geriatric Center Morale Scale and Tokyo Metropolitan Institute of Gerontology Index of Competence scores were significantly higher ( P = .024, .042) at 12 months. At 36 months, there were no significant differences in any QoL items. CONCLUSION Detrimental effects of adjuvant chemotherapy on global QoL, morale, and activity capacity lasted for at least 12 months but were not observed at 36 months.

Chemotherapy-induced alopecia is one of the most difficult adverse events of cancer treatment for patients. However, it is still unknown why anticancer drugs cause hair loss. We aimed to clarify the mechanism of chemotherapy-induced alopecia in mice using an in vivo imaging technique with a two-photon microscope, which enables observation of the deep reaction in the living body in real time. In this study, ICR mice were injected intraperitoneally with cyclophosphamide (120 µg/g). Changes in the hair bulb morphology, subcutaneous vessel permeability, and vessel density were evaluated by two-photon microscopy and conventional methods. In order to determine whether there is a causal relationship between vascular permeability and hair loss, we combined cyclophosphamide (50 µg/g) with subcutaneous histamine. Using two‐photon microscopy and conventional examination, we confirmed that the hair bulbs became smaller, blood vessels around the hair follicle decreased, and vascular permeability increased at 24 hours after cyclophosphamide injection [corrected]. Apoptosis occurred in vascular endothelial cells around the hair follicle. Additionally, hair loss was exacerbated by temporarily enhancing vascular permeability with histamine. In conclusion, cyclophosphamide caused a decrease in vascular density and an increase in vascular permeability, therefore increased vascular permeability might be one of the causes of chemotherapy-induced alopecia.

Background: The randomized controlled trial (RCT) is accepted as the standard clinical trial to decide a standard therapy, but it remains unclear whether or not elderly patients benefit as much as other patients from participation in an RCT. In the RESPECT study (NCT01104935), the relative value of trastuzumab (H) monotherapy as an adjuvant treatment was compared in an RCT with the standard combination treatment with chemotherapy (H+CT) in patients over 70 years old with HER2-positive invasive breast cancer (BC) who received curative surgery. This cohort study was aimed at comparing prognoses between RCT participants (RCT group) and non-participants (Cohort group). Methods: Patients were divided into RCT participants, and those who did not agree to participate in the RCT despite meeting the eligibility criteria and receiving the explanation given by the investigator. In the RCT group patients were randomized to H or H+CT; in the Cohort group treatment was selected for each patient based on the discretion of the treating physician and the patient's wishes without intervention. Treatment categories were divided into three groups: (1) trastuzumab monotherapy group (cH group), (2) trastuzumab plus chemotherapy group (cH+CT group), and (3) those who received either no therapy at all, or any other anticancer therapies without H (cOther group). The primary endpoint was disease-free survival (DFS). Secondary endpoints were overall survival (OS), relapse-free survival, safety, health-related quality of life (HRQOL) and comprehensive geriatric assessment. Results: A total of 275 patients in the RCT group and 123 patients in the Cohort group, in total 398 patients, were enrolled in this study between October 2009 and October 2014. The median age was 74.0 years in the RCT group, 74.5 years in the Cohort group and the median follow-up time was 4.1 years and 3.2 years, respectively. Patients were classified as Stage I: 41.8%, 42.5%; IIA: 41.5 %, 40.8%; IIB: 13.5%, 13.3%; and IIIA: 1.5%. 3.3%, respectively (P = 0.51), there were no significant differences between the two groups. Treatment categories in the Cohort group were: (1) cH group; 43% (n = 52), (2) cH+CT group; 30% (n = 36), cOther group; 27% (n = 32). The planned analysis showed that DFS at 3 years was 91.4% in the RCT group vs 89.3% in the Cohort group (adjusted hazard ratio (HR) = 1.30; 95%CI, 0.72-2.35, P = 0.38). In patients in the cH+CT, cH and cOther group, DFS at 3 years was 92.3%, 89.2% and 82.5%, respectively. DFS in patients in the cH+CT and the cH group was significantly better than that of the cOther group (adjusted HR = 3.79; 95%CI = 1.35-10.64, P = 0.01). DFS in the cH group showed a better tendency compared with cOther (adjusted HR = 2.59; 95%CI, 0.87-7.73, P = 0.08). The incidence of grade 3/4 non-hematological adverse events in the RCT group was relatively higher compared with the Cohort group (18.5% vs 10.8 %, P = 0.05). Conclusion: The prognosis did not vary between the RCT and Cohort groups. H-containing regimens are often chosen for elderly patients with HER2-positive breast cancer. The prognosis of patients who received any H-containing regimen, even H monotherapy, was better than those who were not treated with H. Citation Format: Shinichi Baba, Masataka Sawaki, Yukari Uemura, Tsuyoshi Saito, Kokoro Kobayashi, Hiroaki Kawashima, Michiko Tsuneizumi, Noriko Sagawa, Hiroko Bando, Masato Takahashi, Miki Yamaguchi, Tsutomu Takashima, Takahiro Nakayama, Masahiro Kashiwaba, Toshiro Mizuno, Yutaka Yamamoto, Naruto Taira, Hiroji Iwata, Tatsuya Toyama, Koichiro Tsugawa, Yasuo Ohashi, Hirofumi Mukai. A cohort study to evaluate the efficacy and safety of postoperative adjuvant therapy in HER2-positive elderly breast cancer patients (RESPECT-cohort study) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-14-02.

Purpose To gauge the effects of treatment practices on prognosis for all older patients with HER2-positive breast cancer, particularly to determine whether adjuvant trastuzumab alone can offer benefit over no adjuvant therapy. This report accompanies the RESPECT study, a randomized-controlled trial (RCT) comparing trastuzumab monotherapy with trastuzumab-plus-chemotherapy for early HER2-positive breast cancer.Patients and methods Patients who declined the RCT were treated based on the physician’s discretion. We studied the (1) trastuzumab-plus-chemotherapy group, (2) trastuzumab-monotherapy group, and (3) non-trastuzumab group (no therapy or anticancer therapy without trastuzumab). The primary endpoint was disease-free survival (DFS), which was compared using the propensity-score method.Results We enrolled 398 eligible patients, aged over 70 years, with HER2-positive invasive breast cancer, of whom 275 (69%) were in the RCT, and 123 (31%) were in this cohort group. The median age was 74.5 years. Among cohort group treatment categories were as follows: (1) trastuzumab-plus-chemotherapy group (n = 36, 30%), (2) trastuzumab-monotherapy group (n = 52, 43%), and (3) non-trastuzumab group (n = 32, 27%). A total of 73% of patients received trastuzumab-containing regimens, with or without chemotherapy. The 3-year DFS was 92.3% in the trastuzumab-plus-chemotherapy group, 89.2% in the trastuzumab-monotherapy group, and 82.5% in the non-trastuzumab group. DFS in the non-trastuzumab group was lower than in the trastuzumab-plus-chemotherapy and trastuzumab-monotherapy groups (propensity-adjusted HR: 3.29; 95% CI: 1.15–9.39; P = 0.026). The relapse-free survival in the non-trastuzumab group was lower than in the trastuzumab-plus-chemotherapy and trastuzumab monotherapy groups (propensity-adjusted HR = 7.80; 95% CI: 2.32–26.2, P < 0.0001). Chemotherapy with trastuzumab or trastuzumab monotherapy did not affect health-related quality of life (HRQoL) at 36 months.Conclusions Trastuzumab-treated patients had better prognoses than patients not treated with trastuzumab without deterioration of HRQoL. Thus, trastuzumab monotherapy can be considered for patients who reject chemotherapy.Trial registration number The protocol was registered on the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN 000028476).

OBJECTIVE: The RESPECT trial compared 1-year trastuzumab monotherapy with trastuzumab plus standard chemotherapy as a postoperative adjuvant therapy in HER2-positive elderly breast cancer patients. Primary objective of this study was to verify the noninferiority of 1-year trastuzumab monotherapy to trastuzumab plus chemotherapy in terms of disease free survival, and the planned analysis showed that the difference of restricted mean survival time between two groups at 3 years was 0.45 months (reported by Sawaki at ASCO2018). This report assesses the patients-reported outcomes and health-related quality of life (HRQoL). PATIENTS AND METHODS: The study was done at 99 hospitals in Japan. Elderly women (70 to 80 years old) with HER2-positive, stageI-IIIA invasive breast cancer treated by surgery with clear resection margins were randomly assigned to receive either 1-year trastuzumab or 1-year trastuzumab plus standard chemotherapy, stratified by age, hormone-receptor status, pathological lymph node metastasis and institution. Patients completed questionnaires at baseline, 2 months, 1year, and 3 years after protocol treatment started. The primary outcome was global HRQoL assessed using Functional Assessment of Cancer Therapy-General (FACT-G) total score, and secondary outcomes were chemotherapy-induced peripheral neuropathy (CIPN), instrumental activities of daily living (IADL), anxiety, depression, and subjective happiness. We did the analyses by intention to treat, including patients who completed questionnaires at baseline before start of protocol treatment, and 5point or more change is meaningful in FACT-G total score. This study is registered with ClinicalTrials.gov, NCT01104935. RESULTS: Between Oct 2009 and Oct 2014, 275 patients were enrolled in the study, of whom 9 patients were excluded: 135 assigned to trastuzumab monotherapy and 131 assigned to trastuzumab plus chemotherapy. We detected significant difference between treatment groups for: clinically meaningful HRQoL deterioration rate at 2 months (31% for trastuzumab monotherapy vs 48% for trastuzumab plus chemotherapy; p=0.016) and at 1year (19% vs 38%; p=0.009), clinically meaningful HRQoL improvement rate at 2 months (38% for trastuzumab monotherapy vs 15% for trastuzumab plus chemotherapy; p CONCLUSION: Given the small advantage of adjuvant trastuzumab plus chemotherapy compared to trastuzumab monotherapy for elderly HER-2 positive breast cancer women, decisions about treatment should be informed by the risk for adverse health effects associated with chemotherapy. Citation Format: Kobayashi K, Taira N, Sawaki M, Sagawa N, Baba S, Saito T, Kawahara T, Hagiwara Y, Uemura Y, Shimozuma K, Ohashi Y, Mukai H. Patient-reported outcomes with trastuzumab monotherapy versus trastuzumab plus standard chemotherapy as a postoperative adjuvant therapy in HER2-positive elderly breast cancer patients (RESPECT): A randomized, open-label, phase 3 clinical trial [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 P2-13-02.

PURPOSE Adjuvant trastuzumab monotherapy has not been compared with trastuzumab + chemotherapy. We investigated the relative value of trastuzumab monotherapy for older patients with breast cancer. METHODS This study was an open-label, randomized controlled study with a treatment selection design in which a noninferiority criterion was predefined. Patients aged 70-80 years with surgically treated human epidermal growth factor receptor 2–positive invasive breast cancer received trastuzumab monotherapy or trastuzumab + chemotherapy. The primary end point was disease-free survival (DFS) with assessment of prespecified hazard ratio (HR), relapse-free survival (RFS), adverse events (AEs), health-related quality of life (HRQoL), and restricted mean survival time (RMST). RESULTS The study involved 275 patients (mean age, 73.5 years) who were followed up for a mean of 4.1 years (range, 0.3-8.0 years). The percentages of patients by cancer stage were as follows: I (pT > 0.5 cm), 43.6%; IIA, 41.7%; IIB, 13.5%; and IIIA, 1.1%. Three-year DFS was 89.5% with trastuzumab monotherapy versus 93.8% with trastuzumab + chemotherapy (HR, 1.36; 95% CI, 0.72 to 2.58; P = .51). At 3 years, RMST differed by −0.39 months between arms (95% CI, −1.71 to 0.93; P = .56). Three-year RFS was 92.4% with trastuzumab monotherapy versus 95.3% with trastuzumab + chemotherapy (HR, 1.33; 95% CI, 0.63 to 2.79; P = .53). Common AEs were anorexia (7.4% v 44.3%; P < .0001) and alopecia (2.2% v 71.7%; P < .0001), and grade 3/4 nonhematologic AEs occurred in 11.9% versus 29.8% ( P = .0003) for trastuzumab monotherapy versus trastuzumab + chemotherapy, respectively. Clinically meaningful HRQoL deterioration rate showed significant differences at 2 months (31% for trastuzumab monotherapy v 48% for trastuzumab + chemotherapy; P = .016) and at 1 year (19% v 38%; P = .009). CONCLUSION The primary objective of noninferiority for trastuzumab monotherapy was not met. However, the observed loss of survival without chemotherapy was < 1 month at 3 years. Therefore, and in light of the lower toxicity and more favorable HRQoL profile, trastuzumab monotherapy can be considered an adjuvant therapy option for selected older patients.

Background:There are several small case series about the omental flap for breast reconstructions. However, the long-term oncological safety and the clinical benefits remain uncertain, especially the flap is used as a part of oncoplastic breast surgery. We retrospectively studied 200 patients who underwent oncoplastic breast surgery using the laparoscopically harvested omental flap. Methods:A retrospective chart review of 200 patients who underwent oncoplastic surgery using the omental flap at our institution from April 2002 to March 2016 was performed. All the omental flaps were laparoscopically harvested, and mainly used as a partial reconstruction immediate after breast-conserving surgery (BCS). Short- and long-term laparoscopy-associated complications, local recurrences and cosmetic outcomes were evaluated. Results:Although 46 cases of nipple-sparing mastectomy or skin-sparing mastectomy were included, most of patients underwent partial breast reconstruction after BCS. The successful rate of laparoscopically harvesting of the omental flap was 99.5% (199 out of 200). The rate of complications was 12.0%. Laparoscopy-associated complications occurred in 4 cases (2.0%). The rate of positive margin was 6.5%. Local recurrence occurred in two cases (1.0%) during medial follow-up period of 78 months. In 24 patients (12.0%), the volume of the flap was insufficient. When applied to nipple-sparing mastectomy or skin-sparing mastectomy, volume luck occurred in 32.6% of patients. Cosmetic outcome was mostly satisfactory. Approximately 80% of patients scored good or excellent evaluated with 4 point scale by 3 health professions. The size of the reconstructed breast basically did not change even after radiation therapy. Donor-site scars were almost negligible just like those of laparoscopic cholecystectomy. Conclusions:The laparoscopically harvested omental flap has minimal donor-site morbidity and deformity. The long-term oncological safety is also promising. Although there is a limit of adaptable volume, the omental flap is an attractive option in partial breast reconstruction after BCS. Citation Format: Abe N, Sagawa N, Unesoko M, Zaha H. 200 experiences of oncoplastic surgery with the omental flap reconstruction [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-13-16.

There are several small case series on use of a laparoscopically harvested omental flap (LHOF) for breast reconstruction. However, the long-term oncological safety and clinical benefits of the LHOF remain uncertain, especially in use of the flap in oncoplastic breast surgery. A retrospective chart review was performed for 200 patients who underwent oncoplastic breast surgery using a LHOF at our institution from April 2002 to March 2016. Laparoscopy-associated complications, local recurrence, and cosmetic outcomes were evaluated. Most of the patients underwent partial breast reconstruction immediately after breast-conserving surgery (BCS). The success rate of laparoscopic harvesting of the omental flap was 99.5%. The rate of complications was 12.0% and laparoscopy-associated complications occurred in four cases (2.0%). The rate of a positive margin was 6.5%. Two cases (1.0%) had local recurrence during a median follow-up period of 90 months. In 24 patients (12.0%), the volume of the flap was insufficient. When applied to total reconstruction, volume insufficiency occurred in 32.6% of patients. Cosmetic outcomes were mostly satisfactory. Approximately 80% of patients were rated as good or excellent by evaluation using a 4-point scale and Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software. Donor-site scars were negligible, as in laparoscopic cholecystectomy. The LHOF has minimal donor-site morbidity and deformity, and oncological safety is promising. There is a limit to the adaptable volume, but the LHOF is an attractive option in partial breast reconstruction after BCS.

Chemotherapy-induced alopecia (CIA) is a distressing adverse effect of anticancer drugs; however, there are currently no mechanisms to completely prevent CIA. In this study, we performed a clinical trial to examine whether sodium N-(dihydrolipoyl)-l-histidinate zinc complex (DHL-HisZnNa), an alpha-lipoic acid derivative, prevents CIA in patients with breast cancer. Between July 2014 and May 2015, we performed a multi-center, single arm, clinical trial involving 103 breast cancer patients who received adjuvant chemotherapy at three medical institutions in Japan. During chemotherapy, a lotion containing 1% DHL-HisZnNa was applied daily to the patients’ scalps. The primary endpoint was the incidence of grade 2 alopecia; the secondary endpoints were the duration of grade 2 alopecia, alopecia-related symptoms, and drug-related adverse events. Alopecia was evaluated by three independent reviewers using head photographs taken from four angles. Safety analysis was performed for 101 patients who started the protocol therapy. After excluding one patient who experienced disease progression during treatment, 100 patients who received at least two courses of chemotherapy underwent efficacy analysis. All original 101 patients developed grade 2 alopecia, the median durations of which were 119 days (112–133 days) and 203 days (196–212 days) in the groups treated with four and eight courses of chemotherapy, respectively. Mild or moderate adverse events potentially related to DHL-HisZnNa were observed in 11 patients. Alopecia-related symptoms were observed in 53 patients (52%). The application of 1% DHL-HisZnNa to the scalp did not prevent CIA. However, this drug may promote recovery from CIA. Trial registration number: UMIN000014840.

Background: There are few randomized clinical trials examining adjuvant treatment in elderly breast cancer patients. While obtaining informed consent is essential for participation in clinical studies, there is little information on the frequency of agreement to participate among elderly patients. Furthermore, elderly patients might have specific reasons to decline participation. Patients and Method: The National Surgical Adjuvant Study of Breast Cancer 07 (N-SAS BC 07) is a randomized clinical trial in women over 70 years with HER2-positive primary breast cancer. The primary aim was to investigate the benefit of trastuzumab monotherapy compared with the combination of trastuzumab and chemotherapy. Key inclusion criteria were as follows: women between 70 and 80 years old with HER2-positive breast cancer; underwent curative operation; stage I to IIIA; with sufficient organ function. Patients were randomized to receive either trastuzumab plus chemotherapy or trastuzumab monotherapy. The primary endpoint was disease-free survival, and the secondary endpoints were overall survival, relapse-free survival, safety, health-related quality of life, and cost effectiveness (NCT01104935). It was not possible to predict the number of patients who would agree to participate. In order to comprehensively assess the effect of postoperative adjuvant therapy, we evaluated the reasons why eligible patients declined to participate. The patients were registered in a cohort study to prospectively evaluate the subsequent treatment options and prognosis (07-Cohort). This study examined the obtaining of informed consent for N-SAS BC 07 and the reasons for declining participation, and compared the clinicopathological backgrounds between the N-SAS BC 07 and 07-Cohort groups. Results: 398 eligible patients have been recruited. Informed consent to participate in N-SAS BC 07 has been obtained from 275 patients (69%) and 123 patients (31%) who declined to participate in the RCT have been registered in the 07-Cohort. The common reasons to decline participation in the RCT were "cannot choose the treatment option (55%)", "refused chemotherapy (16%)", "wanted chemotherapy (9%)", "anxious about clinical studies (9%)" and "family opposition (8%)". The mean ages of the patients in N-SAS BC 07 and 07-Cohort were 73.9 and 74.6 years old, respectively. There were no differences in stage, surgical procedure, lymph node metastasis, or co-morbidities between the groups. ER-positive rate was higher in 07-Cohort group compared with N-SAS BC 07 group (53% vs. 37%, p=0.017, χ2 test). Conclusion: While we expected the number of registrants to be small, since N-SAS BC 07 investigated whether elderly patients with HER2-positive breast cancer should undergo chemotherapy, almost 70% of the patients accepted informed consent. The most common reason to decline participation in N-SAS BC 07 was "cannot choose the treatment option" and the majority refused chemotherapy. Furthermore, ER-positivity was higher in the 07-Cohort group, which suggested that ER expression in the patients with HER2-positive breast cancer might influence their decision to participate in the study or to choose the treatment option. Citation Format: Sagara Y, Sawaki M, Taira N, Saito T, Kashiwaba M, Iwata H, Kobayashi K, Nakayama T, Bando H, Mizuno T, Yamamoto Y, Tsuneizumi M, Takahashi M, Yamaguchi M, Kawashima H, Takashima T, Uemura Y, Hozumi Y, Sagawa N, Mukai H, Ohashi Y. A randomized clinical trial of postoperative adjuvant therapy for elderly breast cancer patients: Conditions of obtaining informed consent and reasons for declining participation. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-18-01.

Background: Health-related quality of life (HRQoL) is one of the important outcomes in cancer control trials and has increasingly become the one of the primary foci. Obtaining informed consent from participants is essential for participation in randomized controlled trials (RCTs), but the participation in these RCTs may directly influence HRQoL, because treatment options are determined according to the allocation schedule. To date, only a few studies have compared HRQoL between clinical trial participants and decliners. Patients and Method: The National Surgical Adjuvant Study of Breast Cancer 07 (N-SAS BC 07) is a randomized controlled trial in women with HER2-positive primary breast cancer who are over 70 years of age. The primary aim was to investigate the benefit of trastuzumab monotherapy compared with combination therapy using trastuzumab and chemotherapy. The study concept and design were published in concept paper (Sawaki M. et al., Jpn J Clin Oncol. 2011). In this study, patients were randomized to receive either trastuzumab plus chemotherapy or trastuzumab monotherapy. The primary endpoint was disease-free survival, and the secondary endpoints were overall survival, relapse-free survival, safety, HRQoL, comprehensive geriatric assessment (CGA) and cost effectiveness (protocol ID; NCT01104935). HRQoL and CGA were assessed at registration (baseline), 2 month, 1 year, and 3 years after the start of protocol treatments using the Functional Assessment of Cancer Therapy-General (FACT-G), Hospital Anxiety and Depression Scale (HADS), EuroQol 5 Dimension (EQ-5D), Tokyo Metropolitan Institute of Gerontology (TMIG) index of competence, and the Philadelphia Geriatric Center (PGC) Morale Scale. The patients who declined to participate in N-SAS BC 07 were registered in a cohort study to prospectively evaluate the subsequent treatment options and prognosis (07-Cohort). The same questionnaire that was used in N-SAS BC 07 was used in 07-Cohort to evaluate HRQoL and CGA at entry. Results: Patients were enrolled from October 2012 to October 2016. During this period, 275 and 123 patients were registered in N-SAS BC 07 and 07-Cohort, respectively. The mean age at entry of the patients in the N-SAS BC 07 and 07-Cohort groups was 73.9 and 74.6 years, respectively. The questionnaire response rates at baseline in the patients in N-SAS BC 07 and 07-Cohort groups were 89% and 82%, respectively. There were no significant differences in FACT-G, HADS, EQ-5D, or TMIG index of competence at baseline between the groups, but the mean (standard deviation) scores of PGC Morale Scale in N-SAS BC 07 and 07-Cohort groups were 10.8 (3.3) and 9.9 (3.7), respectively, with the scores being significantly greater in the N-SAS BC 07 group (p=0.020, t-test). Conclusion: The PGC Morale Scale provides a multidimensional approach to assess the psychological state of older people. This study indicated that participation in the RCT did not affect the baseline QoL of elderly patients but suggested that the baseline QoL of the RCT participants was better than decliners. Citation Format: Saito T, Sawaki M, Hozumi Y, Sagawa N, Iwata H, Kashiwaba M, Kawashima H, Kobayashi K, Taira N, Takashima T, Takahashi M, Tsuneizumi M, Nakayama T, Baba S, Bando H, Mizuno T, Yamaguchi M, Yamamoto Y, Uemura Y, Ohashi Y, Mukai H. A randomized controlled trial of postoperative adjuvant therapy for elderly breast cancer patients: Comparison of health-related quality of life between clinical trial participants and decliners. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-11-09.

A 47-year-old woman received adjuvant chemotherapy for breast cancer. On the 13th day of 4 courses of dose-dense AC therapy, she developed a fever. She was orally administered an antibioticfor febrile neutropenia treatment. She showed no improvement of symptoms and gradually presented with new symptoms, including a non-productive cough and dyspnea. After admission, she underwent a further examination, and was provided a diagnosis of pneumocystis pneumonia. It is reported that patients receiving chemotherapy for solid tumors are less likely to develop opportunistic infections. However, patients receiving dose-dense chemotherapy may have a higher risk for developing opportunistic infections than those receiving conventional chemotherapy.

目的:乳癌診療において乳房超音波検査（乳房US）は必須だが，問題点として施行者に依存し，客観性に乏しいことがあげられる．これを克服するために開発された技術の一つにAutomated Breast Volume Scanner（ABVS）がある．今回われわれは，マンモグラフィおよびhand-held USと比較したABVS検出能について検討した．方法:マンモグラフィ，hand-held USおよびABVSを施行した324例のうち，病理組織検査で乳癌と確定診断された連続30例を対象とした．全症例がマンモグラフィ・乳房US（ABVS・hand-held US）を施行した．ABVSによる病変の検出とカテゴリーに関してマンモグラフィとhand-held USのそれらと比較して評価した．結果:浸潤癌は21例（19例が浸潤性乳管癌，1例が浸潤性小葉癌，1例が粘液癌），非浸潤性乳管癌は9例であった．ABVS・hand-held USにより乳癌全例が描出され，かつカテゴリー4以上であった．一方，4例はマンモグラフィではカテゴリー1または2であった．結論:今回の結果からABVSはhand-held US・マンモグラフィに劣らない診断機器であることが示唆される．今後も更なる症例の積み重ねにより，ABVSの診断精度を検討することが重要と考える．

510Background: The relative value of trastuzumab (H) monotherapy as an adjuvant treatment compared to the standard combination treatment with chemotherapy (CT) is not clear for elderly breast cance...