Prospective study of hair recovery after (neo)adjuvant chemotherapy with scalp cooling in Japanese breast cancer patients.

PURPOSE: Scalp cooling during chemotherapy infusion to mitigate alopecia for breast cancer patients is becoming widespread; however, studies regarding hair recovery after chemotherapy with scalp cooling are limited. We conducted a prospective study of hair recovery after chemotherapy with scalp cooling. PATIENTS AND METHODS: One hundred and seventeen Japanese female breast cancer patients who completed planned (neo)adjuvant chemotherapy using the Paxman Scalp Cooling System for alopecia prevention were evaluated for alopecia prevention in our prospective study. We evaluated their hair recovery 1, 4, 7, 10, and 13 months after chemotherapy. Primary outcomes were grades of alopecia judged by two investigators (objective grades) and patients' answers to the questionnaire regarding the use of a wig or hat (subjective grades). RESULTS: Of 117 patients, 75 completed scalp cooling during the planned chemotherapy cycles (Group A), but 42 discontinued it mostly after the first cycle (Group B). Objective and subjective grades were significantly better in Group A than in Group B throughout 1 year, and at 4 and 7 months after chemotherapy. When we restricted patients to those with objective Grade 3 (hair loss of > 50%) at 1 month, Group A exhibited slightly faster hair recovery based on the objective grades than Group B. There was less persistent alopecia in Group A than in Group B. CONCLUSIONS: Scalp cooling during chemotherapy infusion for Japanese breast cancer patients increased the rate of hair recovery and had preventive effects against persistent alopecia.

Scalp cooling for hair loss prevention in female Japanese breast cancer patients receiving (neo)adjuvant chemotherapy.

PURPOSE: Scalp cooling during chemotherapy infusion has been recently reported to have moderate efficacy in the mitigation of chemotherapy-induced alopecia; however, there are few reports on Asian patients. We aimed to clarify the effects of scalp cooling in Japanese women. PATIENTS AND METHODS: Female Japanese breast cancer patients who planned to receive (neo)adjuvant chemotherapy participated in this prospective study on the efficacy of scalp cooling using the Paxman Scalp Cooling System for alopecia prevention. The primary outcomes were the rates of patients with Grade 3 alopecia (defined as hair loss of > 50%) and the rates of patients who used a wig or hat to conceal hair loss 1 month after the last infusion of chemotherapy. The subjects were given a brief questionnaire regarding headaches, bad mood, fatigue, and chills shortly after each cooling. RESULTS: One hundred and forty-three patients participated in the study and used the cooling cap at least once. The mean and median ages of the subjects were 50.6 and 50, respectively (age range 28-76). One hundred and twenty-nine patients completed the planned chemotherapy of 4 to 8 cycles. Among them (7 patients were not evaluable), 74 patients (60.7%) had Grade 3 alopecia 1 month after chemotherapy. Of 80 patients who used the scalp cooling system throughout the planned chemotherapy (1 patient was not evaluable), 36 patients (45.6%) experienced Grade 3 alopecia. CONCLUSION: The efficacy of scalp cooling during chemotherapy infusion for hair loss mitigation in Asian women is similar to that in Caucasian women.

Trends in descriptions of palliative care in the cancer clinical practice guidelines before and after enactment of the Cancer Control Act (2007): content analysis.

BACKGROUND: Palliative care was a priority issue in the Cancer Control Act enacted in 2007 in Japan, and this has resulted in efforts being made toward educational goals in clinical settings. An investigation of how descriptions of palliative care for the treatment of cancer have changed in clinical practice guidelines (CPGs) could be expected to provide a better understanding of palliative care-related decision-making. This study aimed to identify trends in descriptions of palliative care in cancer CPGs in Japan before and after enactment of the Cancer Control Act. METHODS: Content analysis was used to count the lines in all relevant CPGs. We then compared the number of lines and the proportion of descriptions mentioning palliative care at two time points: the first survey (selection period: February to June 2007) and the second survey (selection period: February to December 2015). Descriptions from the CPGs were independently selected from the Toho University Medical Media Center and Medical Information Network Distribution Service databases, and subsequently reviewed, by two investigators. RESULTS: Descriptions were analyzed for 10 types of cancer. The proportion of descriptions in the first survey (4.4%; 933/21,344 lines) was similar to that in the second survey (4.5%; 1325/29,269 lines). CONCLUSIONS: After the enactment of the Cancer Control Act, an increase was observed in the number, but not in the proportion, of palliative care descriptions in Japanese cancer CPGs. In the future, CPGs can be expected to play a major role in helping cancer patients to incorporate palliative care more smoothly.

Predictive Ability of 18F-fluorodeoxyglucose Positron Emission Tomography/computed Tomography for Pathological Complete Response and Prognosis after Neoadjuvant Chemotherapy in Triple-negative Breast Cancer Patients.

OBJECTIVES: The mortality of patients with locally advanced triple-negative breast cancer (TNBC) is high, and pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) is associated with improved prognosis. This retrospective study was designed and powered to investigate the ability of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) to predict pathological response to NAC and prognosis after NAC. METHODS: The data of 32 consecutive women with clinical stage II or III TNBC from January 2006 to December 2013 in our institution who underwent FDG-PET/CT at baseline and after NAC were retrospectively analyzed. The maximum standardized uptake value (SUVmax) in the primary tumor at each examination and the change in SUVmax (ΔSUVmax) between the two scans were measured. Correlations between PET parameters and pathological response, and correlations between PET parameters and disease-free survival (DFS) were examined. RESULTS: At the completion of NAC, surgery showed pCR in 7 patients, while 25 had residual tumor, so-called non-pCR. Median follow-up was 39.0 months. Of the non-pCR patients, 9 relapsed at 3 years. Of all assessed clinical, biological, and PET parameters, N-stage, clinical stage, and ΔSUVmax were predictors of pathological response (p value of 0.0288, 0.0068, 0.0068 respectively; Fischer's exact test). The cut-off value of ΔSUVmax to differentiate pCR evaluated by the receiver operating characteristic (ROC) curve analysis was 81.3%. Three-year disease-free survival (DFS) was lower in patients with non-pCR than in patients with pCR (p=0.328, log-rank test). The cut-off value of ΔSUVmax to differentiate 3-year DFS evaluated by the ROC analysis was 15.9%. In all cases, 3-year DFS was lower in patients with ΔSUVmax <15.9% than in patients with ΔSUVmax ≥15.9% (P=0.0078, log-rank test). In non-pCR patients, 3-year DFS was lower in patients with ΔSUVmax <15.9% than in patients with ΔSUVmax ≥15.9% (P=0.0238, log-rank test). CONCLUSION: FDG-PET/CT at baseline and after NAC could predict pathological response to NAC before surgery and the clinical outcome after surgery in locally advanced TNBC patients.

Clinical experience with nanoparticle albumin-bound paclitaxel, a novel taxane anticancer agent, and management of adverse events in females with breast cancer.

Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is currently approved in Japan for treatment of breast cancer. However, apart from phase I clinical trials, data regarding Japanese patients are scant. In the present study, the efficacy and safety of nab-paclitaxel therapy were retrospectively analyzed in 22 patients with advanced or metastatic breast cancer who were treated at the National Hospital Organization Shikoku Cancer Center between November 2010 and June 2012. The nab-paclitaxel was administered once every three weeks. The median age of the patients was 59 years. The tumors were estrogen-receptor positive and/or progesterone-receptor positive in 63.6% patients. None of the patients had HER2-positive breast cancer. The median number of treatment cycles was six (range, two to 12). Six patients exhibited a partial response; the response rate was 27.3% and the clinical benefit rate was 31.8%. The response rate and clinical benefit rate were higher in patients who received nab-paclitaxel as first- or second-line treatment. The median time to treatment failure was 127 days (range, 27-257). Major adverse events were peripheral neuropathy (59%; Grade 3, 9%), myalgia (59%), rash (45%), and nausea and vomiting (50%). The results suggest that nab-paclitaxel is a well-tolerated and clinically useful anticancer preparation.

Utility of (18)F FDG-PET/CT for predicting prognosis of luminal-type breast cancer.

Postoperative prognosis is better for hormonal receptor-positive breast cancer than for other phenotypes; however, there are no definitive predictive factors for relapse or survival. This study aimed to evaluate the maximum standardized uptake value (SUVmax) on (18)F-fluoro-2-deoxy-glucose positron emission tomography/computed tomography (FDG-PET/CT) and clinicopathological characteristics as possible predictors of postoperative relapse-free survival (RFS) and overall survival (OS) in hormonal receptor-positive breast cancer patients. We evaluated 262 patients with Stage I-III breast cancer diagnosed as luminal type (luminal A, 166; luminal B, 96 patients) who underwent preoperative FDG-PET/CT between January 2006 and December 2011 at two institutions. The relationships among SUVmax and clinicopathological factors (age, clinical T/N stage, nuclear grade, lymph node metastasis and vascular invasion) were evaluated. A phantom study was performed to correct differences in PET/CT analysis between two institutions. The patients were divided according to the SUVmax cutoff on receiver operating characteristic (ROC) analysis for OS (≤6.0 group vs. >6.0 group, AUC = 0.742). Clinical T-factor and nuclear grade were significantly correlated with SUVmax (p < 0.0001 and p = 0.0092, respectively). In the uni- and multivariate analyses using the Cox model for relapse, SUVmax was significant (p = 0.013 and p = 0.055, respectively) among characteristics. RFS curves showed that prognosis was significantly better for the SUVmax ≤ 6.0 group than for the SUVmax > 6.0 group (p = 0.004). Similarly, SUVmax was significant for OS (p = 0.007 and p = 0.008). OS was significantly different between the SUVmax ≤ 6.0 and >6.0 groups (p < 0.001). SUVmax was useful for predicting outcomes in patients with luminal-type breast cancer.

Breast biopsy for mammographically detected nonpalpable lesions using a vacuum-assisted biopsy device (Mammotome) and upright-type stereotactic mammography unit without a digital imaging system: experience of 500 biopsies.

BACKGROUND: The most common diagnostic procedure in the United States for mammographically detected nonpalpable lesions is a combination of a vacuum-assisted biopsy device and a prone-type biopsy table. We have used an upright-type stereotactic mammography unit without a digital imaging system instead of the prone table. PATIENTS AND METHODS: Five-hundred ten biopsies of 506 mammographically detected nonpalpable breast lesions in 488 patients, consisting of 445 lesions with microcalcifications alone, 39 masses without calcifications, and 22 with both masses and microcalcifications, were attempted using a combination of a vacuum-assisted device (Mammotome) and an upright unit without a digital imaging system in a sitting position between May 1999 and February 2007. RESULTS: Breast tissue was obtained in 497 biopsies. Microcalcifications were confirmed radiographically in the tissue of 447 out of 459 biopsies from lesions with microcalcifications (97.4 %). One hundred thirty-seven were diagnosed as malignant, 10 as atypical ductal hyperplasia, 345 as benign, and 1 was not diagnosable. The underestimation rate was 28.0 %. Overall, 26 patients (5.1 %) had vasovagal reactions, while 19 (3.8 %) experienced mild subcutaneous bleeding. Two hundred fifty of 350 lesions, for which biopsy diagnoses were benign, were followed for a median period of 33 months. Four lesions turned out to be malignant. The false-negative rate was 2.8 %. CONCLUSION: The biopsy technique using the combination of the Mammotome and an upright unit without a digital imaging system is cost-effective, safe, and accurate, and should be regarded as one of the standard biopsy methods for mammographically detected nonpalpable lesions.

[Clinical experience with gemcitabine treatment for metastatic breast cancer].

It is difficult to cure recurrent or metastatic breast cancer (MBC). Therefore, it is important to continue treatment for MBC with maintenance of quality of life (QOL). Gemcitabine has been approved for MBC since February 2010. We administered gemcitabine to 39 patients with MBC between February 1, 2010 and March 31, 2012. Depending on the case, taxane or trastuzumab was added. Almost all patients had received prior chemotherapy or hormonal therapy. The median age of patients was 61 years (range, 33-82 years), and the median number of previous treatment regimens was 3 (range, 0-6). The response rate was 15.4%, the disease control rate was 56.4%, and the clinical benefit rate was 33.3%. The main hematological adverse event was neutropenia, and the main non-hematological adverse event was fatigue. Neutropenia could be managed by reducing the gemcitabine dose or withdrawing treatment. Adverse events requiring hospitalization were not observed. These findings suggest that gemcitabine-based regimens are feasible in terms of efficacy and maintenance of QOL for patients with MBC.

Volume-based parameters of 18F-fluorodeoxyglucose positron emission tomography/computed tomography improve disease recurrence prediction in postmastectomy breast cancer patients with 1 to 3 positive axillary lymph nodes.

PURPOSE: To determine whether volume-based parameters on pretreatment (18)F-fluorodeoxyglucose positron emission tomography/computed tomography in breast cancer patients treated with mastectomy without adjuvant radiation therapy are predictive of recurrence. METHODS AND MATERIALS: We retrospectively analyzed 93 patients with 1 to 3 positive axillary nodes after surgery, who were studied with (18)F-fluorodeoxyglucose positron emission tomography/computed tomography for initial staging. We evaluated the relationship between positron emission tomography parameters, including the maximum standardized uptake value, metabolic tumor volume (MTV), and total lesion glycolysis (TLG), and clinical outcomes. RESULTS: The median follow-up duration was 45 months. Recurrence was observed in 11 patients. Metabolic tumor volume and TLG were significantly related to tumor size, number of involved nodes, nodal ratio, nuclear grade, estrogen receptor (ER) status, and triple negativity (TN) (all P values were <.05). In receiver operating characteristic curve analysis, MTV and TLG showed better predictive performance than tumor size, ER status, or TN (area under the curve: 0.85, 0.86, 0.79, 0.74, and 0.74, respectively). On multivariate analysis, MTV was an independent prognostic factor of locoregional recurrence-free survival (hazard ratio 34.42, 95% confidence interval 3.94-882.71, P=.0008) and disease-free survival (DFS) (hazard ratio 13.92, 95% confidence interval 2.65-103.78, P=.0018). The 3-year DFS rate was 93.8% for the lower MTV group (<53.1; n=85) and 25.0% for the higher MTV group (≥53.1; n=8; P<.0001, log-rank test). The 3-year DFS rate for patients with both ER-positive status and MTV<53.1 was 98.2%; and for those with ER-negative status and MTV≥53.1 it was 25.0% (P<.0001). CONCLUSIONS: Volume-based parameters improve recurrence prediction in postmastectomy breast cancer patients with 1 to 3 positive nodes. The addition of MTV to ER status or TN has potential benefits to identify a subgroup at higher risk for recurrence.

Role of maximum standardized uptake value in fluorodeoxyglucose positron emission tomography/computed tomography predicts malignancy grade and prognosis of operable breast cancer: a multi-institute study.

The malignant biological behavior of breast cancer remains obscure on diagnostic images, although understanding the grade of such malignancy is important for selecting appropriate treatment. Therefore, malignancy grades in operable breast cancer were evaluated using positron emission tomography/computed tomography (PET/CT) in a multicenter setting. We prospectively examined the features and prognosis of 344 patients (mean age ± SD: 58.0 ± 12.5 years) with clinical stages I-III breast cancer, who underwent surgical intervention without induction therapy between January 2006 and December 2011. Maximum standardized uptake values (maxSUV) obtained from whole-body fluorodeoxyglucose-PET/CT immediately before surgery were assessed to predict the malignant aggressiveness of tumors including the recurrence-free survival of the patients. Variations in maxSUV among institutions, which are limitations of PET assessments in multicenter studies, were adjusted using a phantom study. The median follow up period was 52 months. The patients were divided into groups according to cut-off maxSUV (≤3.0 vs. >3.0) values established from receiver operating characteristic analysis of recurrence (area under the curve = 0.713). A higher maxSUV was significantly associated with a higher T-factor (p < 0.0001), N-factor (p = 0.0049), nuclear grade (p < 0.0001), negative for estrogen (p = 0.0309), and progesterone receptors (p = 0.0063), positive for human epidermal growth factor receptor 2 (p = 0.0012), lymph node metastasis (p = 0.0128), and vascular invasion (p = 0.0110). Multivariate analysis using Cox proportional hazard regression model revealed high maxSUV and negative estrogen receptor status as significantly prognostic factors (p = 0.033 and p = 0.004, respectively). This study demonstrated that maxSUV on PET/CT as well as estrogen receptor status is useful to predict malignancy grades and the prognosis of patients with breast cancer.

[Genetic counseling and practice of hereditary cancers at Shikoku Cancer Center].

Although the progress in understanding human genetics regarding cancer has been applied to the medical practice of treating hereditary cancers in developed western countries, it is not widely implemented in Japan. We started treating hereditary cancers at NHO Shikoku Cancer Center in November 2000. Our institution has a multidisciplinary team that provides medical care and genetic counseling for patients with hereditary cancers, and their relatives. The team consists of doctors from several related departments, and paramedics including a genetic counselor who participated as of 2009. Medical care of patients with hereditary cancers should not be separated from general oncological practice, but incorporate all medical professionals, including doctors of related departments and paramedic. We have attempted to identify patients with hereditary cancer and their family members and relatives at high risk; we followed them up and provided risk-reducing therapies for them at our cancer center. Here we present the framework of our practice in treating hereditary cancers. We discuss appropriate goals and future perspectives in the field of hereditary cancer in Japan.

[Efficacy and safety of aprepitant in patients with breast cancer].

We retrospectively analyzed the efficacy and safety of aprepitant in breast cancer patients who were treated with FEC(5- fluorouracil, epirubicin, cyclophosphamide)or EC(epirubicin, cyclophosphamide). We divided patients into two groups according to the aprepitant approval period. The rate of severe nausea(@Grade 2)was significantly less in patients with aprepitant(acute 10. 0%, delayed 15. 0%)than those without aprepitant(acute 29. 1%, delayed 30. 9%). Complete response( no vomiting and no use of rescue therapy)in the acute phase was significantly higher in the aprepitant pretreated group than in the no aprepitant group(82. 5% vs 61. 8%, respectively). Moreover, complete response in the delayed phase was also higher in the aprepitant group than in the no aprepitant group(82. 5%vs 58. 2%, respectively). Pre-treatment with aprepitant did not increase adverse events including constipation and elevation of alanine transaminase. The aprepitant was effective in terms of prevention of chemotherapy-induced nausea and vomiting in patients treated with an anthracycline- based regimen.

Detection of isolated ipsilateral regional lymph node recurrences by F18-fluorodeoxyglucose positron emission tomography-CT in follow-up of postoperative breast cancer patients.

Imaging diagnostic methods except for mammograms are not recommended for follow-up of postoperative breast cancer patients in order to detect small recurrences because of the poor survival improvement in earlier randomized trials. However, the use of new imaging modalities may improve survival by detection of small isolated regional lymph node recurrences which are potentially curable. Between April 2006 and December 2008, we used PET-CT to find small recurrences in follow-up of 1,907 postoperative breast cancer patients. A total of 3,280 PET-CT imagings were performed. The median age at PET-CT imaging was 58 years, with a median 48-month interval from definitive surgery to the PET-CT imaging. Twenty-two patients were found to have isolated ipsilateral regional recurrences only by PET-CT (axillary node recurrences in 6, infraclavicular node recurrences in 5, supraclavicular node recurrences in 6, and parasternal node recurrences in 5). All of those recurrences were missed by palpation or were nonpalpable. The pathological lymph node status at the definitive surgery for the primary breast cancer of 22 patients with the isolated ipsilateral regional lymph node recurrences was positive in 17 patients. If patients are limited to those who had pathologically positive node(s) at definitive surgery, the incidence of patients with isolated regional lymph node recurrences found only by PET-CT would be 2.6% (17/663 patients). Seventeen other asymptomatic cancers including contralateral breast cancers were found only by PET-CT. Early detection of isolated loco-regional recurrences of breast cancer is suggested to result in improved survival. Therefore, the use of PET-CT in follow-up of postoperative node-positive breast cancer patients may improve their survival because of early detection of isolated regional lymph node recurrences which are still potentially curable, and screening of other asymptomatic cancers.

Examination of the use of Exemestane in patients with metastatic breast cancer.

BACKGROUND: Endocrine therapy is the preferred systemic treatment for metastatic breast cancer to prolong disease control. Aromatase inhibitors (AIs) are becoming the first choice for postmenopausal patients with metastatic breast cancer. AIs are divided into non-steroidal and steroidal agents. METHODS: We retrospectively analyzed 81 patients with metastatic breast cancer who were administered Exemestane (EXE). The response rate (RR) and clinical benefit rate (CBR) were evaluated. RESULTS: No significant differences were observed between the first-line treatment group and the second- and third-line treatment groups with respect to the CBR. With respect to the CBR, patients with metastases only of the bone and soft tissue had superior results than those with visceral metastasis. There were no significant differences in the RR and CBR of EXE because of differences in prior treatments. On the other hand, no clinical response was achieved in any patients for whom Anastrozole (ANA) was used following EXE. With regard to the switch from EXE to tamoxifen and to medroxyprogesterone acetate, a CB response was not achieved in those receiving EXE, but it was achieved in the others. EXE following ANA had moderate efficacy, with a CBR of 39%. Moreover, a clinical response was achieved in 3 out of 10 patients in whom no response had been achieved with ANA. CONCLUSION: EXE seems to be a useful alternative treatment when the first-line treatment has not been effective. If the use of both agents, ANA and EXE, is planned, it might be desirable to initiate treatment with ANA and then switch to EXE.

Endometrial Metastasis from Breast Cancer during Adjuvant Endocrine Therapy.

It is well-known that tamoxifen increases the risk of endometrial cancer. Although metastasis to the uterus from breast cancer is uncommon, there have been some case reports on uterine metastasis. If an endometrial abnormality is detected, the differential diagnosis of whether the uterine tumor is metastatic or primary is very important to determine the course of treatment. We herein report a case in which we detected a uterine tumor during follow-up after treatment with tamoxifen, and demonstrate that GCDFP-15 is useful in diagnosing metastatic uterine tumors arising from breast cancer.

Metastatic Breast Cancer to the Stomach Resembling Early Gastric Cancer.

Breast cancer metastases to the stomach are very rare. As characteristics of breast cancer metastases to the stomach, metastases of lobular carcinoma, mainly with signet ring cells, are frequently observed, and they are often difficult to distinguish from a primary gastric cancer with signet ring cells. Moreover, because no characteristic symptoms are shown and they involve a submucosal lesion, it is difficult to make a radiographic diagnosis. However, if a gastric lesion is observed after breast carcinoma surgery, differentiation between a gastric primary lesion and a metastatic lesion is very important in order to determine treatment. We encountered a case that was diagnosed as early gastric cancer discovered using an endoscope 2 years after surgery and which was found to be breast cancer metastasis to the stomach by gross cystic disease fluid protein (GCDFP) and cytokeratin (CK) 7/20 immunostaining of the biopsy tissue. Here, we report our findings of this unique case.

False-positive (18)F-fluorodeoxyglucose positron emission tomography/computed tomography caused by incidental injury in a bulky intracystic carcinoma of the breast.

We present a case of right intracystic carcinoma of the breast. An 83-year-old woman was seen at our hospital with a growing bulky mass in the right breast for the last 2 years. Whole-body fluorine-18 fluorodeoxyglucose positron emission tomography and computed tomography ((18)F-FDG-PET/CT) was performed 15 days after mammography (MMG). (18)F-FDGPET/CT showed a right bulky cystic mass and intense FDG uptake in the intracystic nodules as well as in the adjacent extracystic lesion and the underlying pectoralis major muscle. It suggested tumor invasion of the pectoralis major muscle. Right mastectomy combined with partial resection of adherent pectoral muscle was performed. The main cystic lesion was diagnosed to be solid-papillary carcinoma, but the area of the pectoralis muscle was diagnosed to be a "foreign body" inflammation. It was thought that the compression related to MMG and core needle biopsy induced an injury in the bulky breast mass with leakage of contents into adjacent tissue, resulting in the foreign body inflammation. In conclusion, the coexisting foreign body inflammation was responsible for a false-positive (18)F-FDG-PET/CT scan in the current case.

Efficacy and safety of S-1 in patients with metastatic breast cancer: retrospective review in a single institution.

BACKGROUND: It is extremely difficult to bring about a complete cure of metastatic breast cancer: the purpose of treatment is to prolong the patient's survival while maintaining their quality of life (QOL). The current retrospective study was conducted to find whether S-1, an orally administered 5-FU agent, can produce a therapeutic result in patients with recurrent metastatic breast cancer while maintaining their QOL. METHODS: Among the patients who were diagnosed at our institution to have recurrent metastatic breast cancer between November 2001 and December 2008, those who were treated with S-1 were selected and their records retrospectively reviewed. RESULTS: The analysis was conducted on 33 patients. The median number of regimens that these patients underwent was 2 (range 0-6). The overall response rate (ORR), clinical benefit rate (CBR), median time to treatment failure and overall survival were 30%, 42%, 152 days and 338 days, respectively. Among the 11 patients who were treated with S-1 in the first or the second line, ORR and CBR were 45.5 and 63.6%, respectively. Toxicity more than grade 3, leucopenia, neutropenia diarrhea, mucositis, and hand-foot syndrome were found in only 3%. CONCLUSION: S-1 is well-tolerated by patients, promising a therapy while maintaining their QOL. When applied in the early stage of a disease in particular, the agent promises a very effective anti-tumor effect.

[A case of recurrent breast cancer with extensive liver metastasis successfully treated with endocrine therapy].

A 5 6-year-old woman, who underwent breast-conserving surgery and radiation (60 Gy) therapy in July, 1992, at the age of 40, was diagnosed with pT1aN0M0, pStage I. She was administered tamoxifen (TAM) as adjuvant therapy. However, she underwent microdochectomy for DCIS in her contralateral breast in June, 1998. TAM was given till August, 1999. In June, 2006, at the age of 54, 14 years after initial surgery, CT revealed extensive liver masses which were diagnosed as liver metastasis by liver biopsy. Receptor status was positive for ER and PgR, and negative for HER2. AC was started as a first-line chemotherapy ( 4 courses), but did not prove effective. She refused second-line chemotherapy, so letrozole was selected, and subsequently resulted in PR of the liver metastasis. However, 8 months later, with a liver metastasis relapse, exemestane followed by tamoxifen, medroxyprogesterone acetate, and high-dose toremifene were administered sequentially, resulting in long-time disease control. In conclusion, endocrine therapy might be an effective option even in a visceral crisis, if metastatic tumors have showed slow growth and there is positive hormone receptor status.

Feasibility study of docetaxel with cyclophosphamide as adjuvant chemotherapy for Japanese breast cancer patients.

OBJECTIVE: The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [docetaxel (DTX)/cyclophosphamide (CPA)] to doxorubicin/CPA therapy. To introduce TC therapy in Japan, the verification of the safety and tolerability is essential. We performed a collaborative prospective safety study with Okayama University to introduce TC therapy. METHODS: The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008. As post-operative adjuvant chemotherapy, four cycles of TC (DTX 75 mg/m(2) + CPA 600 mg/m(2)) were administered at 3-week intervals. Adverse events were evaluated based on National Cancer Institute-Common Terminology Criteria for Adverse Events ver. 3.0. The safety and completion rate were evaluated as the primary and secondary endpoints, respectively. RESULTS: Regarding hematological toxicity, Grade (G) 4 neutropenia occurred in 71.7% and G3 in 26.4%. G3-4 leukopenia developed in 32.1% and 56.6%, respectively, G4 anemia in 1.9% and G1-2 anemia in 26.4%. Regarding non-hematological toxicity, systemic malaise, skin eruption, edema, myalgia, arthralgia and nausea were noted in most patients. The completion rate was 94.3%, dose reduction was necessary in 7.5% and granulocyte colony-stimulating factor (G-CSF) support was required in 17.0%. On comparison between patients aged 65 years or older and younger than 65 years, the completion rate, dose reduction and incidence of febrile neutropenia (FN) were higher in the elderly patients. G-CSF support was more often needed in this subgroup. CONCLUSIONS: TC therapy is tolerable for Japanese patients, but attention should be paid to the development of FN and neutropenia. The completion rate was lower in the elderly patients, showing that tolerability was not necessarily favorable.