We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB-IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415-1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment.
Female ; Humans ; Uterine Cervical Neoplasms/drug therapy* ; Prospective Studies ; Quality of Life ; Neoplasm Staging ; Chemoradiotherapy ; Chemotherapy, Adjuvant/adverse effects* ; Adjuvants, Immunologic ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Retrospective Studies

BACKGROUND/AIMS: The aim of this study was to evaluate the influence of recent chemotherapy on the patterns of the maximum-standardized uptake value (M-SUV) and sensitivity of 18F-fluoro-deoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) in colorectal cancer. METHODS: We retrospectively analyzed the FDG-PET/CT of 509 patients who underwent surgery for colorectal cancer. Subgroup analysis was performed according to chemotherapy status; 401 patients were not treated with chemotherapy and 108 patients were treated with chemotherapy within 6 months prior to surgery. Pathologic analysis of the surgical specimen was used as the gold standard. RESULTS: The M-SUV was significantly lower in patients treated with chemotherapy than in those not treated with chemotherapy in pathologically confirmed same stages of disease. The difference in the sensitivity of the M-SUV according to chemotherapy status was greatest using a cutoff M-SUV value of 6.4 (p<0.001). The longest diameter of the primary tumor was the most important factor that correlated with M-SUV of the primary tumor irrespective of the chemotherapy effect (p<0.001). The M-SUV of the primary tumor was not an independent predictor of lymph node metastasis in colorectal cancer. CONCLUSIONS: The results indicate that the M-SUV of FDG-PET/CT should be interpreted in the context of concurrent chemotherapy.
Aged ; Antineoplastic Agents/*adverse effects ; Chemoradiotherapy, Adjuvant/adverse effects ; Chemotherapy, Adjuvant/adverse effects ; Colorectal Neoplasms/drug therapy/pathology/*radionuclide imaging ; Female ; Fluorodeoxyglucose F18/diagnostic use/*pharmacology ; Humans ; Male ; Neoplasm Invasiveness ; Neoplasm Metastasis ; Positron-Emission Tomography/methods ; Radiopharmaceuticals/diagnostic use/*pharmacology ; Retrospective Studies

BACKGROUND AND OBJECTIVEConcurrent chemoradiation therapy (CCRT) is the standard treatment for patients with locally advanced nasopharyngeal carcinoma (NPC). The effect of neoadjuvant chemotherapy followed by CCRT has not been determined. Therefore, we conducted 2 phase II studies to evaluate the efficacy and safety of neoadjuvant chemotherapy with a regimen of docetaxel, cisplatin, and 5 fluorouracil (5-Fu) (TPF) followed by radiotherapy and concurrent cisplatin in patients with stage III and IV(A - B) NPC. This article is the preliminary report on treatment related toxicities and response.

METHODSGraded according to the 2002 American Joint Committee on Cancer (AJCC) staging criteria, only patients with stage III or IV(A-B) poorly differentiated or undifferentiated NPC (World Health Organization type II/III) were included. We planned to recruit 52 patients with stage III disease and 64 patients with stage IV(A - B) disease. All patients received neoadjuvant chemotherapy with TPF (docetaxel 75 mg/m(2), day 1; cisplatin 75 mg/m(2), day 1; 5 Fu 500 mg/(m2 x day), continuous intravenous infusion for 120 h), every 3 weeks for 3 cycles, followed by weekly cisplatin (40 mg/m(2)) concurrent with radiotherapy. Three dimensional conformal radiotherapy (3D CRT) and intensity modulated radiotherapy (IMRT) were used. Gross disease planning target volume (PTV), high risk and low risk subclinical PTV doses were prescribed at 70-76 Gy, 66-70 Gy, and 60-61.25 Gy at 1.75-2.0 Gy per fraction. The lower neck or supraclavicular fields may be treated with conventional AP/PA fields for a total of 54 Gy at 1.8 Gy per fraction. Patients were evaluated for tumor response after the completion of neoadjuvant chemotherapy, and at 3 months after radiation according to the Response Evaluation Criteria In Solid Tumors (RECIST). The latest version of the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE 3.0) was used for grading all adverse events.

RESULTSFifty nine patients were evaluable for treatment response. Thirty patients had stage III disease and 29 patients had stage IV(A-B). All patients completed RT to the prescribed dose and 2 cycles of neoadjuvant chemotherapy, with 51 patients (86.4%) completing 3 cycles. A total of 50 (84.7%) and 39 patients (66.1%) completed 4 weeks and 5 weeks of cisplatin during CCRT, respectively. The overall response rate in the primary site and the neck region were 94.9% [complete response (CR) in 25.4%] and 100% (CR in 19.6%) after completing neoadjuvant chemotherapy. At 3 months after RT, the CR rates increased to 96.6% and 90.2%, respectively. After a median follow up of 14.3 months, we observed 5 treatment failures and 2 deaths. The 1 year overall survival, distant metastasis free survival, and locoregional relapse free survival rates were 100%, 95.7%, and 97.7%, respectively. The rates of grade 3/4 myelosuppression and anorexia/nausea/vomiting during neoadjuvant chemotherapy were 55.9% and 16.9%, respectively. The corresponding rates were 11.9% and 23.7% during CCRT. Grade 3/4 mucositis, skin desquamation, and xerostomia occurred in 6.8%, 44.1%, and 27.1% of patients, respectively. There were no treatment related deaths.

CONCLUSIONSNeoadjuvant chemotherapy with TPF followed by CCRT was well tolerated with a manageable toxicity profile. Preliminary results are encouraging and warrant further investigation.

Adult ; Aged ; Anemia ; chemically induced ; etiology ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Chemoradiotherapy ; adverse effects ; Chemotherapy, Adjuvant ; adverse effects ; Cisplatin ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Follow-Up Studies ; Humans ; Leukopenia ; chemically induced ; etiology ; Male ; Middle Aged ; Nasopharyngeal Neoplasms ; pathology ; therapy ; Nausea ; chemically induced ; etiology ; Neoadjuvant Therapy ; adverse effects ; Neoplasm Staging ; Neutropenia ; chemically induced ; etiology ; Radiotherapy, Conformal ; Radiotherapy, Intensity-Modulated ; Remission Induction ; Survival Rate ; Taxoids ; adverse effects ; therapeutic use ; Young Adult

BACKGROUND AND OBJECTIVEConcurrent chemoradiotherapy for cervical carcinoma develops rapidly and has become a common and standard therapy in recent years. Both the local control rate and survival rate of patients were increased and the risk of death fell by 30%-50%. This study aimed to explore the efficacy of concurrent chemoradiotherapy plus adjuvant chemotherapy on and the treatment compliance of the patients with advanced cervical squamous cell carcinoma.

METHODSA total of 156 patients with stage IIa-IIIb cervical squamous cell carcinoma were randomly divided into the concurrent chemoradiotherapy group (experimental group) and radiotherapy group (control group). Intracavity and external beam radiation therapy were administered. At point A, 40-48 Gy were given by 10-12 fractions; at point B, 46-50 Gy were given by 23-25 fractions. In the same time, experimental group was treated by cisplatin (DDP, 40 mg) on day 1, repeated every week. Ten days after radiation therapy, TP regimen was administered as adjuvant chemotherapy.

RESULTSFor the experimental and control groups, the objective response rates were 88.61% and 75.32%, 1-year survival rates were 88.57% and 70.77%, 1-year local control rates were 81.43% and 64.62%, 3-year survival rates were 82.14% and 57.69%, and 3-year local control rates were 75.00% and 46.15%, with significant differences (P<0.05). Quality of life of all patients were significantly improved after treatment (P<0.05).

CONCLUSIONConcurrent chemoradiotherapy plus adjuvant chemotherapy for advanced cervical cancer can improve short-term and long-term survival and local control rates of patients, improve the quality of life, and the toxicity can be tolerated.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Carcinoma, Squamous Cell ; pathology ; therapy ; Chemoradiotherapy ; adverse effects ; Chemotherapy, Adjuvant ; Cisplatin ; adverse effects ; therapeutic use ; Diarrhea ; chemically induced ; etiology ; Dose Fractionation ; Female ; Humans ; Middle Aged ; Neoplasm Staging ; Paclitaxel ; Quality of Life ; Remission Induction ; Survival Rate ; Taxoids ; adverse effects ; therapeutic use ; Uterine Cervical Neoplasms ; pathology ; therapy ; Vomiting ; chemically induced ; etiology

OBJECTIVETo evaluate the feasibility, safety and short-term clinical outcomes of robot-assisted minimally invasive esophagectomy (RAMIE).

METHODSClinical data of 17 patients with esophageal cancer who received RAMIE between April 2016 and July 2016 were analyzed retrospectively.

RESULTSThe age of the patients ranged from 44 to 83. Six patients received neoadjuvant radiochemotherapy while 11 patients underwent surgery alone. All patients were performed by the robot-assisted thoraco-laparoscopic minimally invasive esophagectomy. In-hospital mortality was 0%. None was converted to open transthoracic or laparotomy approach. In the neoadjuvant radiochemotherapy group, 3 patients received pathological complete response while 2 patients were stage II(A and 1 patient was stage II(B. In the surgery alone group, 1 patient was stage I(A, 3 patients were stage II(A, 5 patients were stage II(B, 1 patient was stage III(A and 1 patient was stage III(B. The mean operation time was 195 minutes (range 145 to 305 minutes). The mean blood loss was 60 ml (range 30 to 200 ml). Mean lymph node harvest was 28 nodes. The rate of radical resection was 100%. Median ICU stay was 4.5 days (range 1 to 36 days), and median overall postoperative hospital stay was 15.2 days(range 9 to 45 days). Postoperative complication occurred in 4 (23.5%) patients, including 3 (17.6%) of lung lesion, 2 (11.8%) of hoarseness, 1 (5.9%) of chylothorax, while no anastomotic leakage and arrhythmia was observed.

CONCLUSIONRAMIE for esophageal cancer is feasible and safe with favorable early outcomes.

Aged ; Aged, 80 and over ; Blood Loss, Surgical ; statistics & numerical data ; Chemoradiotherapy, Adjuvant ; Esophageal Neoplasms ; surgery ; therapy ; Esophagectomy ; adverse effects ; methods ; Humans ; Laparoscopy ; Length of Stay ; Lymph Node Excision ; Lymph Nodes ; surgery ; Middle Aged ; Minimally Invasive Surgical Procedures ; adverse effects ; methods ; Neoadjuvant Therapy ; Operative Time ; Postoperative Complications ; etiology ; Retrospective Studies ; Robotic Surgical Procedures ; adverse effects ; methods ; Thoracic Surgery, Video-Assisted ; adverse effects ; methods ; Treatment Outcome

BACKGROUND/AIMS: The objective of this study was to assess the prognostic roles of treatment response and tissue necrosis after chemoradiotherapy (CRT) in locally advanced rectal cancer. METHODS: A total of 243 patients with locally advanced rectal cancer who underwent neoadjuvant CRT were included. Three treatment response groups were classified by their pathological stage results: complete treatment response (CTR), intermediate treatment response (ITR), and poor treatment response (PTR). Three tissue necrosis groups were classified based on tissue pathological results: complete necrosis response (CNR), intermediate necrosis response (INR), and poor necrosis response (PNR). RESULTS: Overall survival (OS) and recurrence-free survival (RFS) rate at three years were 74.5% and 61.3%, respectively. The 3-year OS rates of the CTR, ITR, and PTR groups were 83.7%, 75.9%, and 69.7%, respectively (p < 0.001); the 3-year RFS rates were 76.7%, 69.0%, and 52.1%, respectively (p < 0.001). The 3-year OS rates of the CNR, INR, and PNR groups were 83.7%, 80.6%, and 61.8%, respectively (p < 0.001); the 3-year RFS rates were 76.7%, 68.9%, and 44.3%, respectively (p < 0.001). When compared to CTR/CNR, PTR/PNR was strongly related to an increased risk of recurrence (hazard ratio [HR], 5.53; 95% confidence interval [CI], 2.01 to 15.23 vs. HR, 6.37; 95% CI, 2.29 to 17.74, respectively) in univariate Cox regression. Both PTR and PNR were strongly associated with shorter RFS and OS when compared with CTR and CNR in the multivariate Cox regression. CONCLUSIONS: Tissue necrosis is an equally important prognostic marker as treatment response for oncologic outcomes in locally advanced rectal cancer.
Aged ; Biopsy ; *Chemoradiotherapy, Adjuvant/adverse effects/mortality ; Chi-Square Distribution ; Disease Progression ; Disease-Free Survival ; Female ; Humans ; Kaplan-Meier Estimate ; *Laparoscopy/adverse effects/mortality ; Male ; Middle Aged ; Multivariate Analysis ; Necrosis ; *Neoadjuvant Therapy/adverse effects/mortality ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Proportional Hazards Models ; Rectal Neoplasms/mortality/pathology/*therapy ; Remission Induction ; Retrospective Studies ; Risk Factors ; Time Factors ; Treatment Outcome

OBJECTIVEThe purpose of this study was to investigate the association between single nucleotide polymorphism (SNP) of CCND1 A870G and acute adverse events (AEs) in postoperative rectal cancer patients who received capecitabine-based postoperative chemoradiotherapy (CRT).

METHODSFour hundred patients with stage II and III rectal cancer received postoperative CRT of capecitabine with or without oxaliplatin were accumulated and prostectively studied in this study. The patients were randomly divided into two groups. Two hundred and twenty-eight patients were treated with concurrent capecitabine and radiotherapy (Cap-CRT), and 172 patients were treated with capecitabine and oxaliplatin plus radiotherapy (Cap-Oxa-CRT). Adverse events were graded according to the Common Terminology Criteria for Adverse Events, v. 3.0 (CTCAE v3.0). The genotype of CCND1 A870G in the patients was detected by polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) analysis. The associations between the SNP and acute AEs were indicated by odds ratios (ORs) and 95% confidence intervals (CIs), which were computed with logistic regression model.

RESULTSA total of 136 patients presented severe AEs. Among them the frequencies of the three genotypes GG, GA and AA were 16.9%, 50.7% and 32.4%, compared with 24.6%, 48.1% and 27.3%, respectively, among the patients without severe AEs. Diarrhea was the most common AE, and severe diarrhea occurred in 109 patients. The frequencies of the three genotypes GG, GA and AA were 15.6%, 47.7% and 36.7% among these patients, compared with 24.4%, 49.5% and 26.1%, respectively, among patients without severe diarrhea. Multivariate logistic regression analysis showed a 1.66-fold increased risk for severe diarrhea in patients with AA genotype (95%CI 1.03 - 2.67, P = 0.038) compared with the cases with GG or GA genotypes. Stratified analysis showed that in the Cap-Oxa-CRT group, patients with AA genotype showed a 2.34-fold increased risk for severe diarrhea (95%CI 1.16 - 4.76, P = 0.018) compared with those with GG or GA genotypes, but in the Cap-CRT group, the SNP was not associated with the risk of severe diarrhea.

CONCLUSIONSThe genetic polymorphism of CCND1 A870G might be a potential biomarker for predicting acute AEs in postoperative stage II and III rectal cancer patients treated with adjuvant concurrent chemoradiotherapy of capecitabine and oxaliplatin.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Capecitabine ; Chemoradiotherapy, Adjuvant ; adverse effects ; Cyclin D1 ; genetics ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; Diarrhea ; chemically induced ; etiology ; Female ; Fluorouracil ; administration & dosage ; analogs & derivatives ; Genetic Predisposition to Disease ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Organoplatinum Compounds ; administration & dosage ; Polymorphism, Single Nucleotide ; Postoperative Period ; Prospective Studies ; Rectal Neoplasms ; genetics ; pathology ; surgery ; therapy ; Risk Factors