Docetaxel is a commonly-used anti-cancer chemotherapeutic agent given its efficacy in a large variety of solid tumors. It is associated with various adverse effects one of which is nail toxicity. We report a case of severe onycholysis as a result of treatment with docetaxel in a patient who suffered from metastatic nasopharyngeal carcinoma. The case report will be followed by a discussion on the possible mechanism and preventive strategies for taxane-induced nail toxicity.
Adult ; Female ; Humans ; Nails ; drug effects ; pathology ; Onycholysis ; chemically induced ; Taxoids ; adverse effects

BACKGROUND: Taxanes are an essential class of antineoplastic agents used to treat various cancers and are a fundamental cause of hypersensitivity reactions. In addition, other adverse events, such as bone marrow toxicity and peripheral neuropathy, can lead to chemotherapy discontinuation. This study aimed to evaluate the safety of taxanes in the real world. METHODS: Taxane-associated adverse events were identified by the Medical Dictionary for Regulatory Activities Preferred Terms and analyzed and compared by mining the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database from January 2004 to December 2019. Reported adverse events, such as hypersensitivity reaction, bone marrow toxicity, and peripheral neuropathy, were analyzed with the following signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), Bayesian confidence propagation neural network (BCPNN), and logistic regression methods. Adverse outcome events and death outcome rates were compared between different taxane groups using Pearson's χ2 test, whereas significance was determined at P < 0.05 with a 95% confidence interval (CI). RESULTS: A total of 966 reports of hypersensitivity reactions, 1109 reports of bone marrow toxicity, and 1374 reports of peripheral neuropathy were analyzed. Compared with paclitaxel and docetaxel, bone marrow toxicity following the use of nab-paclitaxel had the highest ROR of 6.45 (95% two-sided CI, 6.05-6.88), PRR of 5.66, (χ2 = 4342.98), information component of 2.50 (95% one-sided CI = 2.34), and empirical Bayes geometric mean of 5.64 (95% one-sided CI = 5.34). Peripheral neuropathy following the use of nab-paclitaxel showed a higher ROR of 12.78 (95% two-sided CI, 11.55-14.14), PRR of 12.16 (χ2 = 4060.88), information component of 3.59 (95% one-sided CI = 3.25), and empirical Bayes geometric mean of 12.07 (95% one-sided CI = 11.09). CONCLUSIONS The results showed that bone marrow toxicity and peripheral neuropathy were the major adverse events induced by taxanes. Nab-paclitaxel exhibited the highest potential for taxane-associated adverse events. Further research in the future is warranted to explain taxane-associated adverse effects in real-world circumstances.
Adverse Drug Reaction Reporting Systems ; Bayes Theorem ; Bridged-Ring Compounds ; Taxoids/adverse effects* ; United States ; United States Food and Drug Administration

To investigate the clinical efficacy of consolidation chemotherapy with docetaxel and cisplatin (DP) in elderly patients of esophageal cancer.
 Methods: Seventy-nine elderly patients of esophageal cancer were randomly divided into the treatment group (38 patients) and the control group (41 patients). Intensity modulated radiation therapy (IMRT) was applied in both groups and prescribed dose was set to 56 to 59.4 Gy in 28 to 33 fractions. The concurrent chemotherapy regime for both groups was as follow: docetaxel 25 mg/m2 plus cisplatin 25 mg/m2, per week. After concurrent chemoradiotherapy, consolidated chemotherapy was applied to the treatment group with docetaxel 60 mg/m2 and cisplatin 75 mg/m2 
for 3 weeks in one cycle. There was no subsequent treatment for the control group.
 Results: The clinical efficacy was assessed in 76 patients. For the treatment group, 31 patients (response rate, 89.2%) obtained effective response, including 10 cases with complete response (CR) and 21 cases with partial response (PR), both of which were significantly more than that in the control group (response rate, 61.5%), with 9 cases of CR and 15 cases of PR. The median progression-free survival was 19.7 months in the treatment group, clearly longer than that in the control group (10.8 months, P=0.04). The overall survival for 1-year, 2-year and 3-year were 78.5%, 57.9% and 37.8% in the treatment group versus 61.2%, 42.3% and 22.7% in the control group (P>0.05), respectively. Grade 1 and 2 adverse effects were commonly observed in both groups, such as hematologic toxicity and radiation-induced esophagitis, but there was no significant difference between the two groups. 
 Conclusion: For elderly patients with esophageal carcinoma, the overall response rate can be significantly improved by concurrent chemoradiotherapy with subsequently consolidated chemotherapy based on docetaxel and cisplatin..
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; Chemoradiotherapy ; adverse effects ; Cisplatin ; adverse effects ; Consolidation Chemotherapy ; adverse effects ; Disease-Free Survival ; Docetaxel ; Esophageal Neoplasms ; mortality ; Esophagitis ; epidemiology ; Female ; Hematologic Diseases ; epidemiology ; Humans ; Male ; Radiotherapy, Intensity-Modulated ; adverse effects ; Remission Induction ; Taxoids ; adverse effects

BACKGROUND AND OBJECTIVEPF regimen is the standard chemotherapy for advanced head and neck cancers including nasopharyngeal cancer. Recently PF has been found to enhance the tumor control by addition of Taxotere. The purpose of this study was to evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of TPF neoadjuvant regimen (taxotere, cisplatin (DDP) and 5-fluorouracil (5-FU)) followed by radical radiotherapy in advanced nasopharyngeal carcinoma (NPC).

METHODSBetween December 2006 and May 2008, 41 patients with newly diagnosed UICC stage III or IV advanced nasopharyngeal cancer were enrolled. There were 29 male and 12 female patients, with a median age of 47 years (range, 29-60 years), and ECOG performance status < or = 2. The initial dose was taxotere 40 mg/m(2) d1, DDP 40 mg/m(2) d1, and 5-FU 400 mg/m(2) d1-5. The treatment was repeated every 3 weeks for two cycles. Each dose of taxotere and DDP was increased by 5 mg/m(2) and 5-FU by 50 mg/m(2), respectively. The dose was escalated after six patients completed two cycles at the initial dose and DLT was assessed. Radiotherapy was started from the 5th week, with 68-72 Gy/34-36 fractions delivered to the nasopharynx and 60-66 Gy/30-33 fractions to the node-positive area.

RESULTSForty patients (79 cycles) were evaluated for toxicity and efficacy of the therapy. No DLT occurred at the dose levels 1-4. At dose level 5, three of six patients experienced DLT including grade III/IV neutropenia lasting more than 1 week. Two of them also had grade III mucositis, leading to the interruption of radiotherapy for more than 1 week. Three more new patients were retreated with the same dose (at dose level 6) under the G-CSF support, and no DLT occurred. Dose escalation continued to level 7, and DLT was found in all of the four patients, including three grade IV neutropenia, one of them had fever and pneumonitis; three grade III diarrhea; and one grade III mucositis lasting 10 days. Dose escalation was stopped and three more new patients were treated again at dose level 5 and no DLT was found. Other severe toxicities included grade III anemia (1 patients), grade III vomiting (4 patients), and grade III weight loss (9 patients). No severe hepatic and renal toxicities were found.

CONCLUSIONTPF neoadjuvant chemotherapy is a safe and effective regimen in the treatment of advanced NPC, with recommended doses of taxotere 60 mg/m(2) d1, DDP 60 mg/m(2) d1, and 5-FU 600 mg/m(2) d1-5.

Adult ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Cisplatin ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Male ; Maximum Tolerated Dose ; Middle Aged ; Mucositis ; chemically induced ; Nasopharyngeal Neoplasms ; drug therapy ; pathology ; radiotherapy ; Neoadjuvant Therapy ; Neoplasm Staging ; Neutropenia ; chemically induced ; Radiotherapy, High-Energy ; adverse effects ; Taxoids ; administration & dosage ; adverse effects ; therapeutic use

OBJECTIVETo compare the efficacy and toxicity of two different regimens as neoadjuvant chemotherapy for breast cancer.

METHODSForty-eight patients with stage II, III breast cancer as proved by cytology biopsy, were treated with either 5-Fu, epirubicin, cyclophosphamide (FEC) or epirubicin, paclitaxel (ET) regimens for 2 cycles every 3 - 4 weeks. Clinical responses in the breast and lymph nodes were assessed after 2 cycles of neoadjuvant chemotherapy. Patients in FEC arm received combination of 5-fluorouracil (5-Fu) 500 mg/m(2) by 4-hour continuous infusion on D1 and D8, epirubicin (EPI) 50 mg/m(2) by intravenous injection on D1, and cyclophosphamide (CTX) 500 mg/m(2) by intravenous injection on D1 and D8. Patients assigned to the ET arm received EPI 60 mg/m(2) by intravenous injection on D1, paclitaxel (TAX) 150 mg/m(2) by 3-hour continuous infusion on D2. All patients were treated by operation 2 weeks later and radiotherapy was added to some.

RESULTSFor primary tumor in the breast, the overall response rate (RR) was 50.0% (12/24) in FEC arm and 79.2% (19/24) in ET arm. One patient showed clinical complete response (cCR), 11 partial response (PR), 12 no change (NC) after the FEC therapy, while 1 patient showed CR, 18 PR, 5 NC after ET therapy. There was no pathologic complete response or progressive disease, though a higher proportion of RR was observed in stage II than stage III patients in these two groups. Clinically palpable axillary lymph nodes which had been found in all 48 patients before 2 cycles of treatment, 50.0% (12/24) in the FEC patients and 66.7% (16/24) in the ET patients became in-palpable. The major toxicity, including leukopenia, gastroenteric reactions, were similar in both groups, but alopecia was more severe and arthralgia, myalgia, neurotoxicity and flushing of face were the unique features of the ET regimen.

CONCLUSIONNeoadjuvant chemotherapy with two different regimens were effective to the primary tumor and axillary metastatic lymph nodes of breast cancer, and the side effects were tolerable. Higher efficacy and more side effects are observed in ET than in FEC regimen.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; Cyclophosphamide ; adverse effects ; therapeutic use ; Epirubicin ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Staging ; Paclitaxel ; adverse effects ; therapeutic use ; Taxoids ; Treatment Outcome

BACKGROUND/AIMS: To determine the efficacy and toxicity of docetaxel as a third-line therapy for patients with relapsed gastric cancer who have undergone modified oxaliplatin-fluorouracil (m-FOLFOX)-4 and modified irinotecan-fluorouracil (m-FOLFIRI) regimens. METHODS: We analyzed 33 patients who had been histologically diagnosed with adenocarcinoma of the stomach and who had progressed after m-FOLFOX-4 and m-FOLFIRI regimens. Patients were treated with cycles of 75 mg/m2 docetaxel on day 1 every 3 weeks. RESULTS: The median age of the patients was 56.0 years (range, 31.0 to 74.0), and 73% of the patients (24/33) had an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients were evaluated in terms of tumor response: five (15%), nine (27%), and 19 (58%) patients experienced a partial response, stable disease, and progressive disease, respectively. The median time to progression was 2.1 months (95% confidence interval [CI], 1.63 to 2.58), and overall survival was 4.7 months (95% CI, 3.20 to 6.20), from the start of the docetaxel regimen. Assessing patients' toxicity profiles, the median number of cycles was 2.0 (range, 1.0 to 12.0). The major hematologic toxicities included grade 3 to 4 neutropenia (19/33, 58%), grade 3 to 4 thrombocytopenia (2/33, 6%), and grade 3 to 4 anemia (5/33, 15%). Neutropenic fever developed in three patients (3/33, 9%). The nonhematological toxicities were nausea and vomiting (10/33, 30%), abdominal pain (4/33, 12%), skin rash (1/33, 3%), and fluid retention (3/33, 9%). CONCLUSIONS: Docetaxel is a feasible third-line therapy regimen for patients with advanced gastric cancer after m-FOLFIRI and m-FOLFOX-4 regimens.
Adenocarcinoma/*drug therapy/mortality ; Adult ; Aged ; Antineoplastic Agents/adverse effects/*therapeutic use ; Antineoplastic Protocols ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Recurrence, Local/*drug therapy ; Republic of Korea/epidemiology ; Salvage Therapy ; Stomach Neoplasms/*drug therapy/mortality ; Taxoids/adverse effects/*therapeutic use

PURPOSE: This study was undertaken to investigate the outcomes associated with docetaxel treatment of Korean patients with hormone-refractory prostate cancer (HRPC) and to compare its clinical efficacies in 1st and 2nd-line settings. PATIENTS AND METHODS: This study was retrospectively performed and included 47 patients with HRPC. The 1st-line group consisted of 19 patients who had not undergone prior chemotherapy, and the 2nd-line group consisted of 28 patients who underwent prior chemotherapy. All patients were treated with 75mg/m2 IV docetaxel every 3 weeks and 5mg of prednisone twice daily with a continuous androgen blockade. RESULTS: Of 47 study subjects, 14 patients (29.8%) had > or = 50% PSA decline from baseline. PSA response was more common in the 1st-line group, but this was not statistically different (42.1% vs. 21.4%, p = 0.114). After a median follow up of 11 months (range, 6-24 months), the 1st-line group showed a longer time to PSA progression (4 vs. 2 months, p = 0.015) and survival (17 vs. 10 months, p = 0.037) than the 2nd-line group. In terms of toxicities, no difference was apparent between the 2 groups. CONCLUSION: In a 1st-line setting, docetaxel is an effective and tolerable agent for Korean HRPC patients, and that its efficacy is limited, although 2nd-line docetaxel is tolerable.
Aged ; Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use ; Humans ; Male ; Middle Aged ; Prostate-Specific Antigen/blood ; Prostatic Neoplasms/*drug therapy/mortality ; Retrospective Studies ; Taxoids/administration & dosage/adverse effects/*therapeutic use ; Treatment Outcome

OBJECTIVETo evaluate the efficacy, toxicity and safety of an new domestic docetaxel in the treatment of pretreated advanced breast cancer.

METHODSFourty-four breast cancer patients who had failed in first-line chemotherapy were included in this trial. They received docetaxel as the second-line chemotherapy. Docetaxel was administered alone at a dose of 70 mg/m2 every 3 weeks. The use of granulocyte colony-stimulating factor to prevent granulocytopenia was not permitted. The response rate and toxicity were evaluated by World Health Organization toxicity scale and performance status by Karnofsky scale.

RESULTSOf the 41 evaluable patients, 4 achieved complete response and 14 partial remission, with a response rate and clinical benefit rate of 43.9% and 85.4%, respectively. Grade 3 or grade 4 neutropenia developed in 42.9%, alopecia in 7.1% and vomiting in 4.8% of these patients. Fluid retention was not observed in this series.

CONCLUSIONThree-week administration of docetaxel alone at a dose of 70 mg/m2 is effective and tolerable. It provides an alternative for the pretreated advanced breast cancer patients.

Adolescent ; Adult ; Aged ; Alopecia ; chemically induced ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; pathology ; Female ; Humans ; Middle Aged ; Neoplasm Staging ; Neutropenia ; chemically induced ; Remission Induction ; Taxoids ; adverse effects ; therapeutic use ; Treatment Outcome ; Vomiting ; chemically induced

BACKGROUND: Second-line chemotherapy offers advanced non-small cell lung cancer (NSCLC) patients a small, but significant increase in survival. Docetaxel is usually administered as a 3-week schedule, yet there is significant toxicity with this therapy. Therefore, a weekly schedule has been explored in several previous trials. In this retrospective study, we compared the efficacy and safety of a weekly schedule and a 3-week schedule of docetaxel monotherapy in a second-line setting. METHODS: Docetaxel was administered as 75 mg/m2 on day 1 every 3 weeks or as 37.5 mg/m2 on day 1 and 8 every 3 weeks until disease progression or severe toxicity developed. RESULTS: From October 2003 to March 2006, a total of 37 patients received docetaxel monotherapy and 36 patients could be evaluated. A total of 135 cycles were administered and then evaluated. The median overall survival was 13.3 months (95% confidence interval: 6.3~20.3) for the weekly schedule and 10.7 months (95% confidence interval: 8.3~13.0) for the 3-week schedule (p=0.41). The median time to progression was 3.0 months (95% confidence interval: 1.9~4.0) and 2.8 months (95% confidence interval: 1.0~4.6), respectively (p=0.41). The response rate was 16.7% for the weekly schedule and 21.1% for the 3-week schedule. The major form of hematologic toxicity was grade 3-4 neutropenia (3-week: 38.9%, weekly: 9.5%). The non-hematologic toxicities were similar between the two schedules. There were no treatment-related deaths. CONCLUSIONS: A docetaxel weekly schedule was very tolerable and it had comparable activity to that of the 3-week docetaxel schedule. Considering the efficacy and tolerability, a docetaxel weekly schedule can be an alternative schedule for the standard treatment of NSCLC in a second-line setting.
Adult ; Aged ; Antineoplastic Agents/*administration & dosage/adverse effects ; Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology ; Drug Administration Schedule ; Female ; Humans ; Lung Neoplasms/*drug therapy/pathology ; Male ; Middle Aged ; Neoplasm Staging ; Retrospective Studies ; Taxoids/*administration & dosage/adverse effects ; Treatment Outcome

Pneumothorax is a complication that rarely occurs after chemotherapy for lung cancer. We report the chest computed tomography findings of a case of spontaneous pneumothorax complicating docetaxel (Taxotere®) treatment for pulmonary metastasis in a 70-year-old woman with pulmonary adenocarcinoma. The patient developed bilateral pneumothoraces, which was induced by changes in the cavitary pulmonary metastatic lesions, after systemic chemotherapy with docetaxel. The chest computed tomography findings and possible mechanisms of this unusual complication are discussed in this report.
Adenocarcinoma ; complications ; diagnostic imaging ; drug therapy ; Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Female ; Humans ; Lung Neoplasms ; complications ; diagnostic imaging ; drug therapy ; Neoplasm Metastasis ; Pneumothorax ; complications ; diagnostic imaging ; drug therapy ; Taxoids ; adverse effects ; therapeutic use ; Tomography, X-Ray Computed