The Efficacy and Safety of Anlotinib Plus Etoposide with Cisplatin/Carboplatin in the First-Line Treatment of Lung Cancer: A Phase II Clinical Study.

Background: The primary aim of this phase II clinical study was to assess the safety and efficacy of combining anlotinib, etoposide, and platinum-based drugs as a first-line treatment for ES-SCLC. Methods: Patients underwent the standard chemotherapeutic regimen, consisting of four courses of etoposide plus cisplatin/carboplatin. Additionally, each patient received a 2-week intervention with anlotinib (12 mg/day, once daily). Anlotinib was continued until disease progression, occurrence of unbearable adverse events (AEs), or withdrawal from the research. Progression-free survival (PFS) served as the primary prognostic measure. Secondary measures included the disease control rate (DCR), objective response rate (ORR), overall survival time (OS), and the incidence of AEs. Results: The DCR and ORR were 97.6% and 91.0%, respectively. Estimated PFS and OS were 5.0 months (95% CI: 1.0-10.8 months) and 13.0 months (95% CI: 8.4-18.6 months), respectively. No unexpected adverse effects were reported during the trial. The most common adverse reactions included anemia (42.22%), hypertension (53.33%), alopecia (40.00%), elevated transaminase (24.40%), and elevated alkaline phosphatase (24.44%). Sixteen cases (35.56%) were classified as AEs of grades 3-5. No deaths attributed to treatment-related causes occurred in any patient during the trial. Conclusion: Combination chemotherapy is currently the first-line therapy for extensive small-cell lung cancer (ES-SCLC). Combining anlotinib with conventional platinum-based chemotherapy demonstrated promising therapeutic outcomes and prognosis in the management of ES-SCLC.

One-stage jaw reconstruction and prosthetic rehabilitation with an iliac flap: a case report and literature review.

BACKGROUND: One-stage jaw reconstruction with fibular flap and prosthetic rehabilitation restores bony and dental continuity simultaneously. It was also called as "jaw-in-a-day (JIAD)" technique. However, bone volume and height of fibular flap may be insufficient for dental implant insertion. The provision of a considerable amount of bone makes an iliac flap the ideal choice in these cases. We present the first case report to document the use of one-stage jaw reconstruction and prosthetic rehabilitation with the iliac flap. CASE PRESENTATION: We modified the conventional JIAD workflow to make it suitable for iliac flap. Two cases were presented who both underwent segmental mandibulectomy for ameloblastoma. Virtual surgical planning was performed in all cases. The iliac crest was positioned upward to provide cortical bone for achieving primary stability of dental implants. Similar to the "all-on-4" procedure, the iliac bone was placed 12 to 15 mm below the occlusal plane to create adequate space for the implant-retained prosthesis. Immediate implant-based dental rehabilitation was performed at same stage. The surgery was successful in all cases without any short-term complications. In the first postoperative week, patients were given a liquid diet through a nasal feeding tube. The liquid diet is advised until 1 month after the surgery. Thereafter, a soft diet is recommended. Patients were advised to resume routine mastication and normal diet 3 months after the surgery. Peri-implantitis occurred in one patient, and additional gingival graft was required. Postoperative function and esthetics were satisfactory at the last follow-up visit. CONCLUSIONS: One-stage jaw reconstruction and prosthetic rehabilitation with the iliac flap are safe and useful for restoring postoperative function and esthetics. It should be used in more cases with a longer follow-up in further studies.

The effect of anterior superior iliac spine preservation on donor site morbidity and function after harvesting a vascularized iliac bone flap.

BACKGROUND: The purpose of this study was to investigate the effect of anterior superior iliac spine (ASIS) preservation on donor site morbidity and function after harvesting a vascularized iliac bone flap (VIBF). METHODS: Patients who underwent jaws reconstruction with VIBF were divided into a maintaining the anterior superior iliac spine (MASIS) group and a not maintaining the anterior superior iliac spine (NMASIS) group. Pain, tenderness, sensory deficit, gait disturbance, and function of the donor site were evaluated before and after the operation. RESULTS: Thirty-three patients were included in this study, of which 18 were in the MASIS group. The incidence of sensory deficit in the MASIS group was significantly lower than that in the NMASIS group (50.0% vs. 86.7%, p = 0.010). Pain, tenderness, gait disturbance, and function did not differ statistically between the two groups. CONCLUSION: Except for sensory deficit, ASIS preservation has minimal impact on donor site morbidity and function.

Iliac crest towards alveolar processes or mandibular inferior margin in mandibular reconstruction with a vascularized iliac bone flap: which is better?

OBJECTIVE: The study aims to compare differences among iliac bone flaps with different iliac crest orientations for the repair of mandibular defects with an aim to analyze their advantages, disadvantages, and effects. MATERIAL AND METHODS: Clinical data and computed tomography scans of all patients who underwent iliac bone flap repair of the mandible in Peking University School and Hospital of Stomatology from January 2016 to April 2021 were collected. Patients were divided into the iliac crest towards alveolar process (Group A) and the iliac crest towards mandibular inferior margin (Group B). Software was used to measure corresponding indicators. The results obtained for the groups were statistically analyzed. RESULTS: The study included 78 patients (25 and 53 in groups A and B, respectively). The symmetry of the LC-type defect was better in group A (p < 0.05). The all-bone width of the alveolar process side in group A was greater than 6 mm; in 15 cases of group B, the width was less than 6 mm (p < 0.05). The intermaxillary distance of two sites were higher in group B (p < 0.05). The bone cortical thickness was significantly thicker in group A (p < 0.05). CONCLUSION: One year after the mandibular body defect was reconstructed with a vascularized iliac bone flap, the iliac crest towards alveolar process group showed better bone symmetry, width, intermaxillary distance, and cortical thickness to meet the planting requirements. CLINICAL RELEVANCE: The use of an iliac crest towards alveolar process may be a better approach for mandible reconstruction.

A survey of the awareness and knowledge of oral cancer among residents in Beijing.

BACKGROUND: The present study aimed to investigate oral cancer awareness and its related knowledge among residents in Beijing. METHODS: A questionnaire survey was conducted among Beijing residents concerning their knowledge of oral cancer, and its prevention and treatment. RESULTS: A total of 3055 questionnaires were completed, 45.8% by males and 54.2% by females. The ages of the respondents ranged from 15 to 93 years; 12.4% were smokers, 1.1% chewed betel nuts, and 82.5% brushed their teeth at least twice a day. Lung cancer was heard of by the most respondents, followed by gastric cancer and liver cancer; oral cancer was the least heard of. More than 60% of respondents were unaware of the risk factors and early signs of oral cancer. CONCLUSIONS: This survey demonstrated a general lack of public awareness and knowledge about oral cancer. Specific measures should be taken to improve public awareness of oral cancer and its prevention and treatment.

Virtual Surgical Planning of Deep Circumflex Iliac Artery Flap for Midface Reconstruction.

OBJECTIVE: Midface reconstruction is challenging for functional and esthetic reasons. The present study analyzed the effect of virtual surgical planning (VSP) of the deep circumflex iliac artery (DCIA) flap for midface reconstruction. PATIENTS AND METHODS: Thirty-four patients who underwent midface reconstruction with the DCIA flap were included in this retrospective study. Of the 34 patients, 16 underwent preoperative VSP, which used a three-dimensionally printed surgical guide, computer-assisted navigation system, and pre-bent titanium implants to transfer VSP into real-world surgery. The other 18 patients underwent traditional midface reconstruction. The following were compared between the two groups: bony contact rate in the buttress region (BCR), dental arch reconstruction rate (DAR), surgical approach, position of vascular anastomosis, and dental implantation rate. The independent-samples t-test and Fisher's exact test were used for analysis. P < 0.05 was considered statistically significant. RESULTS: In total, 12 males and 22 females were included in this study. All patients underwent midface reconstruction using the DCIA flap at the same institution. The median age of patients was 33 years (range: 16-68 years). The average BCR and DAR values in the VSP group were 59.4% ± 27.9% and 87.5% ± 18.9%, respectively, which were significantly higher compared with the non-VSP group (P = 0.049 and P = 0.004, respectively). The dental implantation rate in the VSP group (50.0%) was significantly higher compared with the non-VSP group (11.1%; P = 0.023). The intraoral approach for tumor ablation and vascular anastomosis was the most frequent choice in both groups. There was no significant difference between the two groups. All patients were satisfied with facial symmetry postoperatively. CONCLUSIONS: VSP could effectively augment the effect of midface reconstruction with the DCIA flap. Stronger bone contact in the buttress region and higher DAR provide more opportunity for dental implantation, which might be the best solution to improve masticatory function in patients with midface defects.

The efficacy of iodine-125 interstitial brachytherapy for the treatment of locally advanced adenoid cystic carcinoma of the base of tongue: a non-surgical approach.

PURPOSE: The present study retrospectively evaluated the effectiveness and safety of iodine-125 interstitial brachytherapy for treatment of primary locally advanced adenoid cystic carcinoma (ACC) of the base of tongue (BOT). MATERIAL AND METHODS: This study was a retrospective analysis of data of 19 patients with ACC, who were treated with iodine-125 interstitial brachytherapy between March 2008 and April 2018. Overall survival (OS), disease-free survival (DFS), local control (LC), and radiation-related toxicities were determined. Factors affecting the outcomes were evaluated. RESULTS: Six males and 13 females were included in our study, with a median follow-up time of 35 months. 3- and 5-year OS rates were 71.5% and 47.6%, respectively. 3- and 5-year LC rates were 88.5% and 34.5%, respectively. 3- and 5-year DFS rates were 54.7% and 21.9%, respectively. A significant difference was observed in patients with or without brain metastases for OS rate. No severe acute toxicity was observed, while severe late toxicity was observed in one patient. CONCLUSIONS: The results suggest that iodine-125 interstitial brachytherapy is an effective and safe option for the treatment of primary locally advanced ACC of the base of the tongue, with reasonably satisfactory LC and OS.

Surgery combined with 125I brachytherapy for treatment of carcinoma ex pleomorphic adenoma of the parotid gland.

OBJECTIVE: The aim of this study was to investigate the effectiveness and safety of surgery combined with 125I seed brachytherapy for treatment of carcinoma ex pleomorphic adenoma (CXPA) of the parotid gland and to identify the factors associated with prognosis. STUDY DESIGN: We conducted a retrospective analysis of data of patients with CXPA of the parotid gland treated with surgery plus 125I seed brachytherapy at the Peking University School of Stomatology Hospital between December 2003 and July 2018. RESULTS: Fifty-five patients (median age, 51 years) were included in the study. Median follow-up was 50.5 months. The 3-, 5-, and 10-year overall survival rates were 91.1%, 91.1%, and 81.5%, respectively. The 3-, 5-, and 10-year local control rates were all 85.2%. Grades 1-3 adverse effects occurred in 22 patients; no grade 4 reactions occurred. T stage, N stage, tumor invasiveness, perineural invasion, and surgical margins significantly affected local control rates. Lymph node metastasis and perineural invasion were independent predictors of poor local control. Lymph node metastasis was an independent predictor of poor survival. CONCLUSIONS: Surgery plus 125I seed brachytherapy appears to be an effective and safe treatment for CXPA of the parotid gland. T stage, N stage, tumor invasiveness, and perineural invasion are factors influencing prognosis.

Efficacy of combined surgery and 125 I seed brachytherapy for treatment of primary mucoepidermoid carcinoma of the parotid gland.

BACKGROUND: This study aimed to determine the effectiveness and safety of surgery combined with postoperative 125 I seed brachytherapy for treatment of primary mucoepidermoid carcinoma (MEC) of the parotid gland. METHODS: Retrospective analysis of data of patients with MEC (n = 108) treated with surgery plus postoperative 125 I seed brachytherapy between 2004 and 2016. Overall survival (OS), disease-free survival (DFS), local control rate (LCR), distant metastasis, and radiation-associated toxicities were analyzed, and factors affecting outcomes were evaluated. RESULTS: The 5- and 10-year OS were 98.8% and 95.8%, respectively. The DFS and LCR at 5 and 10 years were all 91.4%. Age ≥ 60 years (hazard ratio [HR] = 6.86, 95% confidence interval [CI]: 1.54-30.55) and T4 disease (HR = 7.15, 95% CI: 1.40-36.52) were poor prognostic factors. Acute radiation-associated toxicities were minor. CONCLUSION: Surgery plus 125 I seed brachytherapy appears to be an effective treatment for parotid gland MEC, capable of providing satisfactory outcomes with few complications.

Evaluation of the accuracy of computer-assisted techniques in the interstitial brachytherapy of the deep regions of the head and neck.

PURPOSE: We sought to investigate the feasibility and accuracy of computer-assisted techniques in the interstitial brachytherapy of the deep regions of the head and neck. MATERIALS AND METHODS: A computer-assisted brachytherapy workflow was applied to 10 patients with tumors in the deep regions of the head and neck. Based on the brachytherapy treatment preplan, we constructed a digital stereotactic model to accurately transfer the virtual plan into the navigation system, and subsequently printed the individual templates. The navigation system and the individual template were combined together to visualize and guide brachytherapy needle implantation. Preoperative and intraoperative image data were reconstructed and registered to measure and analyze the needle deviation. RESULTS: A total of 58 needles were successfully inserted in 10 patients with the guidance of computer-assisted techniques and a mean deviation of 5.2 mm. The inserting trajectories and depths of the needles were as follows: from the parotid and masseter regions to the infratemporal fossa or skull base, the range was 15.7-74.6 mm; from the submandibular and retromandibular regions to the infratemporal fossa or skull base, the range was 15.6-70.6 mm; from the infraorbital region to the pterygomandibular region, the range was 63.7-69.7 mm; and from the periorbital region to the intraorbital region, the range was 47.6-61.8 mm. The dose distribution met the treatment requirement well. CONCLUSIONS: The computer-assisted interstitial brachytherapy workflow was proven to be feasible and accurate for the deep regions of the head and neck.

Intraoral Anastomosis of Deep Circumflex Iliac Artery Perforator Flap for Maxillary Reconstruction.

Maxillary reconstruction is one of the most challenging areas of reconstructive surgery. This report describes a case of a 33-year-old male with osteoblastic osteosarcoma of the maxillary. The patient received radical resection and reconstruction with a deep circumflex iliac artery perforator flap (DCIAPF). The flap was harvested with a 4 × 2 cm osseous flap and a 6 × 8 cm skin island supplied by terminal perforators from the deep circumflex iliac artery. Anastomosis was accomplished on the ipsilateral facial vessels with deep circumflex iliac vessels through an intraoral approach. The donor site and the flap were observed to have completed primary healing 2 weeks after the surgery. The DCIAPF may be a satisfactory single-flap option for maxillary reconstruction with less donor-site complications.

The role of 125I interstitial brachytherapy for inoperable parotid gland carcinoma.

PURPOSE: The treatment of inoperable parotid gland carcinoma is challenging and controversial. The purpose of this paper was to present our experience in treating this malignancy using 125I interstitial brachytherapy. METHODS AND MATERIALS: Thirteen patients with advanced carcinomas of the parotid gland were included and treated with 125I interstitial brachytherapy in Peking University School and Hospital of Stomatology from January 2003 to December 2015. All patients were treated with 125I interstitial brachytherapy as a sole modality for the primary tumor. Furthermore, all of them were treated with neck dissection with/without adjunctive external beam radiotherapy for the neck, simultaneously. The prescription dose of interstitial brachytherapy was 140-160 Gy. RESULTS: Median followup was 56 months (range: 8-105 months). The 2-year and 5-year local control rates were 91.7% and 58.2%, respectively. The 2-year and 5-year overall survival rates were 100% and 61%, respectively. No cervical lymph node metastasis was observed during the followup. No interstitial brachytherapy-related severe complications occurred. Facial nerve function was preserved well. CONCLUSIONS: 125I interstitial brachytherapy is a feasible and effective treatment for inoperable parotid gland carcinomas without severe complications. And neck dissection with/without external beam radiotherapy is necessary for patients with cervical metastasis or at high risk of cervical metastasis.

Postoperative iodine-125 interstitial brachytherapy for the early stages of minor salivary gland carcinomas of the lip and buccal mucosa with positive or close margins.

BACKGROUND: The purpose of this study was to present our preliminary exploration of safety and efficacy of postoperative low-dose-rate brachytherapy for the early clinical stages of minor salivary gland carcinomas of the lip and buccal mucosa. METHODS: Twenty-seven patients with the early stages of minor salivary gland carcinomas of the lip and buccal mucosa received postoperative 125 I seed interstitial brachytherapy from March 2005 to May 2015. Actuarial likelihood estimates for local control, overall survival, and disease-free survival were calculated by Kaplan-Meier method. RESULTS: The actuarial 3-year, 5-year, and 10-year local control rates were 94.7%, 82.9%, and 82.9%, respectively. The actuarial 3-year, 5-year, and 10-year overall survival rates were 93.3%, 93.3%, and 77.8%, respectively. No patient experienced toxicity above grade 2. CONCLUSION: Postoperative 125 I seed interstitial brachytherapy is an alternative to radical surgery for early stages of minor salivary gland carcinomas of the lip and buccal mucosa, which offers satisfactory cosmetic and functional outcomes. © 2017 Wiley Periodicals, Inc. Head Neck 39: 572-577, 2017.

The efficacy of iodine-125 permanent brachytherapy versus intensity-modulated radiation for inoperable salivary gland malignancies: study protocol of a randomised controlled trial.

BACKGROUND: Radiation therapy is the method of choice for subjects with inoperable salivary gland malignancies. I-125 brachytherapy, delivering a high radiation dose to a tumor but sparing surrounding normal tissues, is supposed to be ideal modality for the treatment of salivary gland malignancies. We designed a randomised controlled clinical trial to compare the efficacy of I-125 permanent brachytherapy (PBT) versus intensity-modulated radiation therapy (IMRT) for inoperable salivary gland malignancies. METHODS/DESIGN: In this study, inclusion criteria are subjects with inoperable salivary gland malignancies, aged 18-80 years, have provided informed consent, with at least one measurable tumor focus, be able to survive ≥3 months, Karnofsky performance status ≥60, have adequate hematopoietic function of bone marrow, have normal liver and kidney function, and are willing to prevent pregnancy. Exclusion criteria include a history of radiation or chemotherapy, a history of other malignant tumors in the past 5 years, receiving other effective treatments, participating in other clinical trials, with circulatory metastasis, cognitive impairment, severe cardiovascular and cerebrovascular diseases, acute infection, uncontrolled systemic disease, history of interstitial lungdisease, and being pregnant or breast feeding. The study will be conducted as a clinical, prospective, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 90 subjects. Subjects with inoperable salivary gland malignancies are randomised to receive either I-125 PBT or IMRT, with stratification by tumor size and neck lymph node metastasis. Participants in both groups will be followed up at 2, 4, 6, 9, 12, 15, 18, 21 and 24 months after randomization. The primary outcome is local control rate of the primary site (based on imaging findings and clinical examination, RECIST criteria) in 1 year. Secondary outcomes are progression-free survival, overall survival, quality of life (QOL) measured with the European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and QLQ-H&N35) of Chinese version, and safety of treatment. Chi-squared test is used to compare the local control rates in both groups. The survival curves are estimated by the Kaplan-Meier method, and log-rank test is used to test the significant difference. DISCUSSION: Only few observational studies have investigated the effect of I-125 PBT on inoperable salivary gland malignancies. To our knowledge, this is the first randomised controlled trial to investigate the efficacy of I-125 PBT for subjects with inoperable salivary gland malignancies, and will add to the knowledge base for the treatment of these subjects. TRIAL REGISTRATION: The study is registered to Clinical Trials.gov ( NCT02048254 ) on Jan 29, 2014.

[Clinical investigation on distant metastases of salivary gland carcinoma after being treated by surgery combined with 125I internal brachytherapy].

OBJECTIVE: To investigate clinical features of distant metastases (DM) and analyze clinicopathologic risk factors associated with DM from salivary gland carcinomas after being treated by surgery combined with 125I internal brachytherapy. METHODS: Between October 2001 and March 2010, 197 patients with salivary gland carcinoma were treated by surgery combined with 125I internal brachytherapy and had follow-up for 2 years or more. Univariate and multivariate analyses were performed to evaluate clinicopathologic risk factors that might influence the risk of distant metastases. RESULTS: DM occurred in 28 of 197 patients (14.2%). The commonest site of distant metastases overall was the lung 89.3% (25/28), followed by bones 17.9% (5/28) and liver (4/28). DM developed after an average interval of (44.2±45.8) months from the time of initial diagnosis, and the mean interval was 64 months. The average time to death after the diagnosis of DM was only (9.7±13.4) months, and the mean time was 12 months. The 3-year locoregional control rate and survival rate were 90.8%, and 87.8% respectively,and the 5-year ones 84.0% and 81.0%, respectively. Univariate analyses revealed that the risk of distant metastases was significantly influenced by locoregional tumor failure (F=26.997, P<0.01) and histologic differentiation (F=1.592, P<0.01). Multivariate analysis of freedom from distant metastases revealed that locoregional control (F=29.332, P<0.01) significantly influenced this end point. CONCLUSION: Salivary gland carcinoma could achieve high local control rate after being treated by surgery combined with 125I internal brachytherapy, and the average interval from diagnosis to DM was prolonged, DM was significantly influenced bylocoregional control.

Human milk fortifier with high versus standard protein content for promoting growth of preterm infants: A meta-analysis.

OBJECTIVE: To compare the growth of preterm infants fed standard protein-fortified human milk with that containing human milk fortifier (HMF) with a higher-than-standard protein content. METHODS: Published articles reporting randomized controlled trials and prospective observational intervention studies listed on the PubMed®, Embase®, CINAHL and Cochrane Library databases were searched using the keywords 'fortifier', 'human milk', 'breastfeeding', 'breast milk' and 'human milk fortifier'. The mean difference with 95% confidence intervals was used to compare the effect of HMF with a higher-than-standard protein content on infant growth characteristics. RESULTS: Five studies with 352 infants with birth weight ≤ 1750 g and a gestational age ≤ 34 weeks who were fed human milk were included in this meta-analysis. Infants in the experimental groups given human milk with higher-than-standard protein fortifier achieved significantly greater weight and length at the end of the study, and greater weight gain, length gain, and head circumference gain, compared with control groups fed human milk with the standard HMF. CONCLUSIONS: HMF with a higher-than-standard protein content can improve preterm infant growth compared with standard HMF.