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1.
Clin Transl Sci ; 16(12): 2665-2674, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37815272

RESUMEN

Anticancer drugs are essential in the treatment of serious diseases, but their applications are limited by drug lags. This study investigated the characteristics of anticancer drugs approved in Japan over the past 20 years and compared the drug lag trends between Japan and the US. We assessed the changes in drug lag between Japan and the US and the factors affecting the drug lags using publicly available data for anticancer drugs approved in Japan from January 2001 to December 2020. A total of 299 anticancer drugs were approved in Japan in the last 20 years. The approval lag median between the US and Japan was 498 days (16.6 months), peaking in 2002, and decreasing annually thereafter. The minimum approval lag was 173.5 days (5.7 months) in 2018. Multivariate regression analysis revealed that "global simultaneous strategy," "catch-up strategy," and "immunotherapy" are major factors shortening the drug lag. In the past decade, 226 anticancer drugs were approved in Japan. The drug lag for anticancer drugs between Japan and the US peaked in 2002, after which it declined sharply to less than a year. However, the lag was shortest in 2018.


Asunto(s)
Antineoplásicos , Aprobación de Drogas , Humanos , Estudios Transversales , Japón , Factores de Tiempo , Antineoplásicos/uso terapéutico
2.
JAMA Netw Open ; 6(4): e238875, 2023 04 03.
Artículo en Inglés | MEDLINE | ID: mdl-37115550

RESUMEN

Importance: A surrogate end point (SEP) is an end point used in clinical trials as an alternative for measuring the true clinical benefit. The use of SEPs in trials shortens their duration. Objectives: To investigate the use of SEPs in clinical trials to support the approval of anticancer drugs and to determine whether confirmatory studies that use overall survival (OS) as an end point are being conducted in Japan. Design, Setting, and Participants: In this cross-sectional study, drug approvals and background information were obtained from publicly available information, such as the Pharmaceuticals and Medical Devices Agency website, for anticancer drugs approved in Japan from January 2001 to December 2020. Data analysis was performed from September 2021 to March 2022. Main Outcomes and Measures: Characteristics of approved oncology drugs in Japan, end points for pivotal clinical trials, and outcomes of confirmatory trials using OS as an end point following drug approval. Results: There were 299 anticancer drugs approved in Japan during the study period. Of these, 142 (47.5%) were molecular-targeted drugs, the most common of which targeted non-small cell lung cancer. There were 111 (37.1%) anticancer drugs with orphan designation. From 2001 to 2005, OS was used as an end point in 1 approval (3.6%); however, from 2006 to 2020, OS was used in 86 approvals (31.7%). Of the 212 anticancer drugs approved on the basis of SEPs, confirmatory studies with OS as the end point were conducted for only 37 approvals (17.5%); for the remaining 175 approvals, studies are under way for 35 approvals (16.5%), were waivered for 75 approvals (35.4%), and were not conducted for 65 approvals (30.7%). Furthermore, in 20 drug approvals (9.4%), the conducted confirmatory studies were not effective in determining the OS, but the drugs were approved following re-examination. Conclusions and Relevance: The findings of this study suggest that starting from 2005, the use of OS as an end point has increased in studies supporting the approval of anticancer drugs in Japan. However, even after 2005, approximately two-thirds of these approvals were SEP based. Postmarketing surveillance studies of the true end points are necessary to validate the use of SEPs.


Asunto(s)
Antineoplásicos , Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Humanos , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Japón , Estudios Transversales , Neoplasias Pulmonares/tratamiento farmacológico , Antineoplásicos/uso terapéutico , Biomarcadores , Preparaciones Farmacéuticas
3.
Int J Surg Case Rep ; 105: 108067, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37023686

RESUMEN

INTRODUCTION AND IMPORTANCE: Infarction occurs occasionally in benign mammary tumors but is extremely rare in breast cancer, with few cases having been reported. PRESENTATION OF CASE: A 53-year-old woman presented to our hospital with a mass and pain in the upper lateral region of the right breast. She underwent a needle biopsy and was histologically diagnosed as having invasive carcinoma. A ring-enhancing spherical mass was seen on contrast-enhanced computed tomography and magnetic resonance images. She underwent a right partial mastectomy with sentinel lymph node biopsy for T2N0M0 breast cancer. Macroscopically, the tumor was a yellow mass. Histopathologically, the site contained extensively necrotic tissue with foam cell aggregation, lymphocytic infiltration, and fibrosis in the periphery. No viable tumor cells were observed. The patient was followed up without postoperative chemotherapy or radiotherapy. CLINICAL DISCUSSION: Ultrasound examination performed before the biopsy showed blood flow inside the tumor, but a review of the histopathological tissue after surgery revealed generally low viability of the tumor cells in the biopsy specimen, and the possibility that the tumor had a strong tendency to be necrotic from the beginning was considered. It is presumed that some immunological mechanism was working. CONCLUSION: We have encountered a case of breast cancer with complete infarct necrosis. Infarct necrosis may be present if a contrast-enhanced image shows ring-like contrast.

4.
J Surg Case Rep ; 2023(2): rjad051, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36818814

RESUMEN

Interparietal inguinal hernia, an exceedingly rare type of inguinal hernia in which the hernia sac anatomically lies between the tissue layers of the abdominal wall, is difficult to diagnose from physical findings. Given the few reports on interparietal inguinal hernias, this condition has remained fairly unrecognized. Herein, we report the successful imaging and laparoscopic diagnoses as well as repair of an interparietal inguinal hernia. Atypical physical findings and computed tomography data help in the diagnosis of an interparietal inguinal hernia. The laparoscopic approach is useful and feasible for both the diagnosis and treatment of interparietal inguinal hernia.

5.
Int J Surg Case Rep ; 92: 106810, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-35180589

RESUMEN

INTRODUCTION: Contralateral axillary lymph node metastasis (CAM) is rare, especially in primary breast cancer. PRESENTATION OF CASE: A 71-year-old woman visited our hospital after noticing a mass in her right breast. A mass of 5 cm in diameter with skin infiltration was palpable on the medial side of the right breast. She underwent a needle biopsy and was diagnosed with invasive ductal carcinoma. On various imaging modalities, there were no distant metastases but bilateral axillary lymph node metastases were found. She underwent preoperative chemotherapy and showed a clinical partial response. After thorough discussion, she opted for surgery and underwent partial mastectomy of the right breast and bilateral axillary lymph node dissection. Histopathological examination revealed residual breast tumor and one metastatic axillary lymph node on each side. Postoperative radiotherapy and hormone therapy were performed. The patient is alive and recurrence-free as of 1 year after the start of treatment. CONCLUSION: CAM is often regarded as distant metastasis, but can be considered curable if there is no distant metastasis to other organs. CAM without distant metastasis to other organs should be treated with curative intent in order to avoid a disadvantage to the patient.

6.
World J Clin Cases ; 9(12): 2801-2810, 2021 Apr 26.
Artículo en Inglés | MEDLINE | ID: mdl-33969062

RESUMEN

BACKGROUND: Definitive chemoradiotherapy (dCRT) using cisplatin plus 5fluorouracil (CF) with radiation is considered the standard treatment for unresectable locally advanced T4 esophageal squamous cell carcinoma (ESCC). Recently, induction chemotherapy has received attention as an effective treatment strategy. CASE SUMMARY: We report a successful case of a 59-year-old female with unresectable locally advanced T4 ESCC treated by two additional courses of chemotherapy with CF after induction chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) followed by dCRT. Initial esophagogastroduodenoscopy (EGD) detected a type 2 advanced lesion located on the middle part of the esophagus, with stenosis. Computed tomography detected the primary tumor with suspected invasion of the left bronchus and 90° of direct contact with the aorta, and upper mediastinal lymph node metastasis. Pathological findings from biopsy revealed squamous cell carcinoma. We initially performed induction chemotherapy using three courses of DCF, but the lesion was still evaluated unresectable after DCF chemotherapy. Therefore, we subsequently performed dCRT treatment (CF and radiation). After dCRT, prominent reduction of the primary tumor was recognized but a residual tumor with ulceration was detected by EGD. Since the patient had some surgical risk, we performed two additional courses of CF and achieved a clinically complete response. After 14 mo from last administration of CF chemotherapy, recurrence has not been detected by computed tomography and EGD, and biopsy from the scar formation has revealed no cancer cells. CONCLUSION: We report successful case with tumor remnants even after DCF and subsequent dCRT, for whom a complete response was finally achieved with two additional courses of CF chemotherapy. Additional CF chemotherapy could be one radical treatment option for residual ESCC after treatment with induction DCF followed by dCRT to avoid salvage surgery, especially for high-risk patients.

7.
World J Gastroenterol ; 27(6): 534-544, 2021 Feb 14.
Artículo en Inglés | MEDLINE | ID: mdl-33642827

RESUMEN

BACKGROUND: Pancreaticoduodenectomy (PD) for advanced gastric cancer is rarely performed because of the high morbidity and mortality rates and low survival rate. However, neoadjuvant chemotherapy for advanced gastric cancer has improved, and chemotherapy combined with trastuzumab may have a preoperative tumor-reducing effect, especially for human epidermal growth factor receptor 2 (HER2)-positive cases. CASE SUMMARY: We report a case of successful radical resection with PD after neoadjuvant S-1 plus oxaliplatin (SOX) and trastuzumab in a patient (66-year-old male) with advanced gastric cancer invading the pancreatic head. Initial esophagogastroduodenoscopy detected a type 3 advanced lesion located on the lower part of the stomach obstructing the pyloric ring. Computed tomography detected lymph node metastasis and tumor invasion to the pancreatic head without distant metastasis. Pathological findings revealed adenocarcinoma and HER2 positivity (immunohistochemical score of 3 +). We performed staging laparoscopy and confirmed no liver metastasis, no dissemination, negative lavage cytological findings, and immobility of the distal side of the stomach due to invasion to the pancreas. Laparoscopic gastrojejunostomy was performed at that time. One course of SOX and three courses of SOX plus trastuzumab were administered. Preoperative computed tomography showed partial response; therefore, PD was performed after neoadjuvant chemotherapy, and pathological radical resection was achieved. CONCLUSION: We suggest that radical resection with PD after neoadjuvant chemotherapy plus trastuzumab is an option for locally advanced HER2-positive gastric cancer invading the pancreatic head in the absence of non-curative factors.


Asunto(s)
Terapia Neoadyuvante , Neoplasias Gástricas , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Gastrectomía , Humanos , Masculino , Páncreas , Pancreaticoduodenectomía , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/cirugía
8.
Int J Surg Case Rep ; 81: 105788, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33756165

RESUMEN

BACKGROUND: Mutation-positive patients who develop unilateral breast cancer require different treatments, such as prophylactic mastectomy of the contralateral breast, from those used for other breast cancer patients. If a mutation is found before surgery, it is necessary to consider a surgical procedure that includes reconstruction. For BRCA mutation-positive patients, a suitable treatment must be selected. In Japan, a test for BRCA mutation has been covered by health insurance since 2020, making it possible to preoperatively test patients who are suspected of being positive. We report a case of simultaneous bilateral breast cancer that was found to be BRCA mutation-positive preoperatively and underwent bilateral subcutaneous mastectomy and breast reconstruction. CASE PRESENTATION: A 57-year-old woman was admitted to our hospital after a breast cancer screening revealed a mass in the left breast. She had a family history of breast cancer, including her sister, aunt, and cousin. She was suspected of being malignant with a mass on both sides of her breast on imaging. She underwent needle biopsy and was diagnosed as having bilateral invasive ductal carcinoma, for which she was placed on preoperative chemotherapy. Due to the strong family history of bilateral breast cancer, the patient was recommended to undergo a BRCA gene-mutation test and she consented. The result was positive for BRCA1 mutation. Although it was judged that bilateral breast-conserving surgery was sufficiently possible, bilateral subcutaneous mastectomy and breast reconstruction were performed based on BRCA mutation-positive status. DISCUSSION: Performing a preoperative BRCA test may change the surgical procedure. BRCA tests are beneficial to patients, but the timing of the tests is important. Care must be taken not to force the patient. CONCLUSIONS: Knowing whether the patient is BRCA mutation-positive is extremely important for selecting surgical procedures and treatment methods. BRCA testing should be recommended for patients who are strongly suspected of being positive, but the decision should be the patient's. It is therefore necessary to provide accurate information and engage in a dialogue with the patient, but the medical staff should not pressure the patient to have the test.

9.
World J Clin Cases ; 9(2): 509-515, 2021 Jan 16.
Artículo en Inglés | MEDLINE | ID: mdl-33521123

RESUMEN

BACKGROUND: Inguinal hernia repair is one of the most common general surgical operations worldwide. We present a case of indirect inguinal hernia containing an expanded portosystemic shunt vessel. CASE SUMMARY: We report a 72-year-old man who had a 4 cm × 4 cm swelling in the right inguinal region, which disappeared with light manual pressure. Abdominal-pelvic computed tomography (CT) revealed a right inguinal hernia containing an expanded portosystemic shunt vessel, which had been noted for 7 years due to liver cirrhosis. We performed Lichtenstein's herniorrhaphy and identified the hernia sac as being indirect and the shunt vessel existing in the extraperitoneal cavity through the internal inguinal ring. Then, we found two short branches between the expanded shunt vessel and testicular vein in the middle part of the inguinal canal and cut these branches to allow the shunt vessel to return to the extraperitoneal cavity of the abdomen. The hernia sac was returned as well. We encountered no intraoperative complications. After discharge, groin seroma requiring puncture at the outpatient clinic was observed. CONCLUSION: If an inguinal hernia patient has portal hypertension, ultrasound should be used to determine the contents of the hernia. When atypical vessels are visualized, they may be shunt vessels and additional CT is recommended to ensure the selection of an adequate approach for safe hernia repair.

10.
Radiol Case Rep ; 16(1): 55-61, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33193929

RESUMEN

Primary lymphoma of the breast is a rare disease, accounting for about 0.5% of all primary breast tumors. Often found as a solitary indolent mass, it is difficult to distinguish from breast cancer on imaging and is often diagnosed for the first time based on histological findings. Diffuse large B-cell lymphoma is the most common histological subtype. A 48-year-old woman visited our hospital because of a painless mass in the left breast. Breast cancer was suspected based on the imaging findings. A core needle biopsy was performed, and the invasive ductal carcinoma was diagnosed. Partial mastectomy and sentinel lymph node biopsy were performed. The resected specimen was finally diagnosed as diffuse large B-cell lymphoma based on immunohistochemical staining. The patient was treated with R-CHOP and intrathecal injection of methotrexate. The patient remains alive without recurrence 4 years later. Awareness of primary breast lymphoma is essential for accurate and timely diagnosis and avoidance of unnecessary surgery.

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