Role of modern neoadjuvant chemoradiotherapy in locally advanced thymic epithelial neoplasms

2020 ◽  
pp. 030089162096798
Author(s):  
Yirui Zhai ◽  
Dazhi Chen ◽  
Yushun Gao ◽  
Zhouguang Hui ◽  
Liyan Xue ◽  
...  
Keyword(s):  
Adverse Events ◽  
Thymic Carcinoma ◽  
Locally Advanced ◽  
Survival Rates ◽  
Pathologic Complete Response ◽  
Neoadjuvant Chemoradiotherapy ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Free Survival ◽  
Epithelial Neoplasms

Purpose: To improve resectability in patients with stage III–IVA thymic epithelial neoplasms, neoadjuvant chemotherapy and radiotherapy are considered. This retrospective study aimed to investigate the efficacy and safety of neoadjuvant therapies using modern techniques in thymic epithelial neoplasms. Methods: We included 32 patients with Masaoka stage III–IV disease treated at our institution from January 2010 to December 2017. Data regarding clinicopathologic characteristics, treatment protocols, toxicities, and survival were collected. Response was evaluated according to the Response Evaluation Criteria in Solid Tumours 1.1. Survival was assessed using the Kaplan-Meier method. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Results: Neoadjuvant radiotherapy alone, chemotherapy alone, sequence chemoradiotherapy, and concurrent chemoradiotherapy were administered to 10 (31.3%), 9 (28.1%), 3 (9.4%), and 10 (31.3%) patients, respectively. Twenty-nine patients (90.6%) underwent R0 resection. The median follow-up time was 38.0 months (3.3–109.5 months). After neoadjuvant therapy, 18 patients (56.3%) achieved partial response and 14 (43.8%) had stable disease. Pathologic complete response was achieved in 6 patients (18.8%), all of whom had thymic carcinoma. The 5-year overall and progression-free survival rates were 90.9% and 67.5%, respectively. For patients with thymic carcinoma, the 5-year overall and progression-free survival rates were 80.0% and 66.2%, respectively. Grade 3 toxicities were observed in only 1 patient (leukopenia). Conclusions: For patients with primary unresectable thymic neoplasms, neoadjuvant chemoradiotherapy is an efficient and safe choice, with favorable response and survival and moderate toxicities. Patients with thymic carcinoma might benefit more from neoadjuvant therapies.

scholarly journals Analysis of treatment outcomes in patients with progressive locally advanced non-resectable and disseminated medullary thyroid cancer receiving vandetanib outside of clinical trials (Russian experience)

2020 ◽  
Vol 10 (2) ◽  
pp. 46-53
Author(s):  
I. S. Romanov ◽  
А. М. Mudunov ◽  
S. О. Podvyaznikov ◽  
А. V. Ignatova ◽  
Yu. V. Alymov
Keyword(s):  
Overall Survival ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Treatment Outcomes ◽  
Medullary Thyroid Cancer ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Free Survival ◽  
Medullary Thyroid

The study objective is to perform retrospective analysis of the efficacy and safety of vandetanib for metastatic and non-resectable medullary thyroid cancer in routine clinical practice. Materials and methods. We analyzed treatment outcomes in 46 patients treated with vandetanib. We also evaluated progression-free survival, overall survival, time to progression, and frequency of adverse events. Results. At a median follow-up time of 27.4 months (range: 2.5–106.5 months) and median duration of vandetanib therapy of 21 months, disease progression was registered in 32.6 % of cases, whereas stable disease was observed in 28.3 % of cases and 8.7 % of study participants demonstrated partial response. One patient had complete response to treatment. Almost one-third of patients (28.2 %) died, including 2 individuals whose death was not associated with cancer. The one-year and three-year progression-free survival rates were 67.3 % and 33.3 %, respectively; the two-year and five-year overall survival rates were 82.4 % and 29.4 %, respectively. The efficacy of therapy was confirmed by a 79.4 % decrease in the serum level of calcitonin after treatment initiation. Side effects were observed in 33.9 % of patients (primarily skin and gastrointestinal toxic reactions) and were easily managed in most of the cases. Eight individuals (17.4 %) required cessation of vandetanib due to adverse events. Conclusion. Our findings suggest high efficacy and acceptable safety profile of vandetanib in the treatment of progressive locally advanced non-resectable and disseminated medullary thyroid cancer

scholarly journals Comparison between 5-day decitabine and 7-day azacitidine for lower-risk myelodysplastic syndromes with poor prognostic features: a retrospective multicentre cohort study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Byung-Hyun Lee ◽  
Ka-Won Kang ◽  
Min Ji Jeon ◽  
Eun Sang Yu ◽  
Dae Sik Kim ◽  
...  
Keyword(s):  
Adverse Events ◽  
Myelodysplastic Syndromes ◽  
Lower Risk ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Free Survival ◽  
Prognostic Features ◽  
Multicentre Cohort Study ◽  
Treatment Responses ◽  
Grade 3

AbstractNumerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS). However, reports that compare the two HMAs, decitabine and azacitidine, in patients with lower-risk (low and intermediate-1) MDS are limited. We compared 5-day decitabine and 7-day azacitidine regimens in terms of treatment responses, survival outcomes, and adverse events in patients with lower-risk MDS with poor prognostic features. The overall response rates (ORRs) were 67.2% and 44.0% in the patients treated with decitabine and azacitidine, respectively (P = 0.014). While the median progression-free survival (PFS) was significantly better in the patients treated with decitabine than in those treated with azacitidine (P = 0.019), no significant differences in event-free and overall survival rates were observed between the two groups. Multivariate analysis revealed that compared with azacitidine treatment, decitabine treatment is significantly associated with a higher ORR (P = 0.026) and longer PFS (P = 0.037). No significant differences were observed in the incidence of grade 3 or higher haematologic adverse events in response to the two HMAs. In conclusion, in lower-risk MDS, especially with poor prognostic features, ORR and PFS were significantly better with 5-day decitabine treatment than with 7-day azacitidine treatment, with comparable safety.

Dose intensive chemotherapy (Cx) in advanced thymoma: Initial report of Japan Clinical Oncology Group trials (JCOG 9605 and 9606)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7080-7080
Author(s):  
H. Kunitoh ◽  
T. Tamura ◽  
H. Fukuda ◽  
K. Nakagawa ◽  
K. Takeda ◽  
...  
Keyword(s):  
Thymic Carcinoma ◽  
Local Therapy ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Initial Report ◽  
Free Survival ◽  
Unresectable Stage ◽  
Short Course ◽  
Ecog Ps

7080 Background: Thymoma is considered to be sensitive to Cx. Dose intensive Cx might well be suitable for such tumors, especially in combination with local therapy. Objectives of the trials were to evaluate the safety and efficacy of the dose intensive CODE (cisplatin[C]- vincristine[O]- doxorubicin[D]- etoposide[E]) Cx in thymoma. The primary endpoint was progression-free survival time (PFS). Methods: Patients (pts) with 15–70 years of age with histologically documented Cx-naïve thymoma with stage IVa/IVb disease (JCOG 9605) or unresectable stage III disease (JCOG 9606) were eligible. Tumors of other histology, such as thymic carcinoma, carcinoid or lymphoma were excluded; pts were to have ample organ function and ECOG PS of 0–2. Myasthenia was allowed. Signed consent form was obtained. Pts received CODE Cx of 9 weeks (w): C 25 mg/m2 Cx day 1 on each w1–9; O 1mg/m2 d1 on w1,2,4,6,8; D 40 mg/m2 d1 and E 80 mg/m2 d1,2,3 on w 1,3,5,7,9. Cx courses were supported by GCSF. Steroids were used only for antiemesis. Those with stage III disease (JCOG 9606) went on to surgery, if judged to be resectable, and post-operative radiotherapy (RT) of 48Gy; those with unresectable disease received 60Gy RT. Results: From Jul./97 to Apr./05, 53 pts were entered to the studies. Five were found ineligible because of different histology. Pt characteristics and response to the Cx were summarized in the table . Toxicity of the Cx was mainly hematologic and generally well tolerated, with no toxic death; 70% of the pts completed planned 9 weeks. Thirteen pts in JCOG 9606 (stage III) received thoracotomy; tumor was resected in 11 pts, completely in 9 (39% of enrolled pts). Pathologic CR was observed in 3. The median PFS was 9.5m for stage IV and 4.5 y for stage III diseases. Overall survival at 2 & 5 yrs were 82% & 57% for stage IV and 96% & 77% for stage III pts. Conclusions: Short-course, dose intensive Cx was active against thymoma. Although it does not seem to bring long PFS in stage IV pts, it could improve resectability in limited disease. [Table: see text] No significant financial relationships to disclose.

A retrospective evaluation of locally advanced thymoma and thymic carcinoma: Factors influencing the prognosis after local treatment modalities.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e18510-e18510
Author(s):  
Ülkü Yalçintas Arslan ◽  
Caglayan Geredeli ◽  
Nuriye Özdemir ◽  
Aydin Ciltas ◽  
Ozlem Sonmez ◽  
...  
Keyword(s):  
Thymic Carcinoma ◽  
Early Stage ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Local Treatment ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Treatment Modalities ◽  
Surgical Removal ◽  
Clinicopathologic Characteristics

e18510 Background: Aim of the study was to determine the relationship between clinicopathologic characteristics and treatment modalities for locally advanced thymic malignancies(TM). Methods: We retrospectively reviewed medical records of 107 patients(pts) who treated from 1992 to 2012 in medical oncology service of 7 tertiary hospital. 21 pts who presented metastatic disease and 31 pts who had early stage at the time of diagnosis were excluded. Results: A total of 55 patient’s data were analyzed. Median age was 46(17-73) years. Median follow-up was 33(1-103) months(mts). 65% of pts was male. Histopathologic diagnosis were as follows: thymoma type A-B2 ( TA-B2) 29 , thymoma type B3 (TB3) 10 and thymic carcinoma (TC) 16. 42 of pts underwent surgery, but total resection of the tumor have been achieved at only 28 pts(6 TC and 22 TA-B2 or TB3).30 pts have stage III diasease (mostly thymoma 23/30). 43 pts treated with mediastinal radiotherapy ( 21 adjuvant, 22 primary). A cisplatin containing regimen has been received 23 pts in the adjuvant setting. 31 pts were given as primary chemotherapy (ADOC, PAC and EP). Overall response rate was 81.6% with first-line chemotherapy. There was no apparent response in 3 pts(3/23) with thymoma and 4 pts(4/8) with TC. 20 pts have experienced a disease progression and 27 pts died ( 8 of these cases died from other unrelated causes). Median progression free survival was 45 (30-59)mts. Kaplan-Meier survival analysis estimated that overall survival of the pts with stage III disease were relatively longer than stage IVA ones, but it can not reach statistical significance (median 78 vs 45 mts,p=.11). Prognosis of TC pts were considerably worse than TB3 and TA-B2 (median 17 vs 45 vs 76 mts respectively,p=.01). Although there was no a statistical difference between pts who underwent total tumor removal and who did not, we have seen a trend toward better survival in pts who were suitable to triple modality therapy(median 79 vs 45 mts,p=.27). Conclusions: Cisplatin based chemo plus mediastinal radiotherapy may provide a chance of achieving a long-lasting remission in locally advanced TM. But, complete surgical removal of the tumor are still the mainstay of treatment.

Safety and efficacy of docetaxel combined with cisplatin as induction chemotherapy followed by cisplatin concurrent chemoradiotherapy plus gemcitabine as adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma: A prospective and multicenter phase II trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6064-6064
Author(s):  
Zhi Hui Wang ◽  
Peijian Peng ◽  
Siyang Wang ◽  
Yumeng Liu ◽  
Zhong Lin
Keyword(s):  
Radiation Therapy ◽  
Adjuvant Chemotherapy ◽  
Induction Chemotherapy ◽  
Treatment Strategy ◽  
Objective Response ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Free Survival ◽  
Safety And Efficacy

6064 Background: Radiation therapy is the only curative treatment modality for nonmetastatic nasopharyngeal cancer (NPC). Concurrent chemoradiation (CCRT) is the standard treatment strategy for NPC in locally advanced stages. However, the results after such treatment are suboptimal. Clearly, novel treatment strategies are needed to further improve patients’ survival rates. This trial aimed to determine the safety and efficacy of a new treatment strategy. Methods: Patients with stage III – IVa-b NPC received TP (docetaxel 75 mg/m2, cisplatin 75 mg/m2 every 3 weeks for 2-3 cycles) followed by cisplatin chemotherapy concurrently with either 3-dimentional conformal radiation therapy or intensity-modulated radiation therapy plus gemcitabine (1000mg/m2 every 2 weeks for 2 cycles) as adjuvant chemotherapy. Objective response rates and acute toxicity were assessed based on RECIST (1.1) and CTCAE v.4.0, respectively. Kaplan-Meier analysis was used to calculate survival rates. This trial is registered with the Chinese Clinical Trials Registry, number ChiCTR-OIC-17011464. Results: From July 2010 to July 2017, 20 eligible patients with nonmetastatic stage III-IVb NPC were enrolled. The objective response rates were 90% (3 complete responses [CRs] and 15 partial responses [PRs]) after two or three cycles of induction chemotherapy (ICT) and 100% (17 CRs and three PRs) after CCRT plus gemcitabine adjuvant chemotherapy, respectively. With a median follow-up time of 41 months, the 3-year overall survival rates were 90% (18/20,95% confidence interval [CI], 76.9%-100%).The 3-year progression-free survival, distant metastasis-free survival, and local progression-free survival rates were 80% (16/20,95% CI, 62.5%-97.5%), 85% (17/20,95% CI, 69.4%-100%),95% (19/20,95% CI, 85,4%-100%), respectively. The most frequent grade 3–4 toxicities were neutropenia (3/20,15%) and nausea (2/20,10%) after ICT and thrombocytopenia (6/20,30%) and leukopenia (6/20,30%) after CCRT plus gemcitabine adjuvant chemotherapy. Conclusions: Neoadjuvant TP followed by concurrent chemoradiation plus gemcitabine as adjuvant chemotherapy was well tolerated and produced promising outcomes in patients with LA-NPC in this hypothesis-generating study. The authors concluded that randomized controlled trials are warranted to definitively confirm this aggressive and potentially efficacious strategy. Clinical trial information: ChiCTR-OIC-17011464.

scholarly journals Rationale and design of a phase II trial of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study)

2020 ◽  
Vol 12 ◽  
pp. 175883592092784 ◽  
Author(s):  
Tadaaki Yamada ◽  
Junji Uchino ◽  
Yusuke Chihara ◽  
Takayuki Shimamoto ◽  
Masahiro Iwasaku ◽  
...  
Keyword(s):  
Phase Ii ◽  
Antitumor Agents ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Open Label ◽  
Free Survival ◽  
The Pacific ◽  
Secondary Endpoints

Background: In the PACIFIC study, progression-free survival (PFS) and overall survival (OS) of patients with unresectable, locally advanced, stage III non-small cell lung cancer (NSCLC) were prolonged by durvalumab as maintenance therapy after radical concurrent chemoradiotherapy using platinum-based antitumor agents. However, no data were obtained to reveal the efficacy of durvalumab after radiation monotherapy in patients unsuitable for chemoradiotherapy. Here, we describe an ongoing single-arm, prospective, open-label, multicenter phase II trial of durvalumab in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study). Methods: Durvalumab at 10 mg/kg body weight is administered every 2 weeks after radiation therapy until individual patients meet the discontinuation criteria. The treatment duration is up to 12 months. The primary endpoint is the 1-year PFS rate. Secondary endpoints are response rate, PFS, OS, and safety. Durvalumab treatment after radiation monotherapy is expected to prolong 1-year PFS rate and have acceptable adverse events. Discussion: We are conducting an intervention study to investigate the safety and efficacy of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy.

A pilot study of neoadjuvant chemoradiotherapy for unresectable locally advanced adherent colon cancer: Assessing local tumor response.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 727-727
Author(s):  
Xin Yu ◽  
WeiWei Xiao ◽  
Rong Zhang ◽  
LuNing Zhang ◽  
Bo Qiu ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Progression Free Survival ◽  
Bladder Function ◽  
Cancer Center ◽  
R0 Resection ◽  
Primary Tumors ◽  
Free Survival ◽  
Local Progression

727 Background: To analyze the outcomes of neoadjuvant chemoradiotherapy (neoCRT) in the management of unresectable locally advanced adherent colon cancer (LAACC). Methods: 40 unresectable LAACC patients were identified from Sun Yat-Sen university cancer-center Database from October 2010 to December 2014. Unresectability was determined by multidisciplinary consultation (MDT) according to image examination or confirmed by exploratory laparotomy. NeoCRT followed by surgery and postoperative chemotherapy were given to these patients. There were 27 males and 13 females. Median age was 56 years old. The location of primary tumors were as sigmoid 31, descending colon 3, ascending colon 5, and cecum1, respectively. All the patients were treated with 45-50Gy/25F using 3D-CRT or IMRT, and concomitantly with capecitabine-based chemotherapy every 3 weeks. Surgery was scheduled 6-8 weeks after completion of radiotherapy. Results: A total of 40 patients completed neoCRT and 33 patients (82.5%) received radical resection for the locally diseases, with R0 and R2 resection in 30 and 3 patients, respectively. Seven patients were assessed as unresectable after neoCRT and 3 of them received only colostomy while the other 4 continued chemotherapy. Pathological complete response was documented in 8 patients (20.0%). Multivisceral resection was necessary in 15 patients (36.6%). Among the 33 patients underwent curative surgery, bladder invasion was noticed at diagnosis in 17 patient and bladder function was preserved in all these patients, with full bladder preserving approach in 6 and partial cystectomy in 11 patients. Grade-2 post-operative complications were observed in 4 patients (10.0%) with no 30-day mortality. Median follow-up was 26 months. For all the patients, the 3-year overall survival, local progression-free survival and progression-free survival were 70.8%, 88.2%, 74.5%, respectively. Conclusions: NeoCRT is an effective strategy for the treatment of unresectable LAACC, with high R0 resection rate, satisfactory organ preservation, good local control and acceptable treatment toxicity. NeoCRT in LAACC is worthy of further clinical research.

Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer.

1998 ◽  
Vol 16 (10) ◽  
pp. 3316-3322 ◽  
Author(s):  
H Choy ◽  
W Akerley ◽  
H Safran ◽  
S Graziano ◽  
C Chung ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Combined Modality Therapy ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Free Survival ◽  
Locally Advanced Nsclc

PURPOSE Combined modality therapy for non-small-cell lung cancer (NSCLC) has produced promising results. A multiinstitutional phase II clinical trial was conducted to evaluate the activity and toxicity of paclitaxel, carboplatin, and concurrent radiation therapy on patients with locally advanced NSCLC. PATIENTS AND METHODS Forty previously untreated patients with inoperable locally advanced NSCLC entered onto a phase II study from March 1995 to December 1996. On an outpatient basis for 7 weeks, patients received paclitaxel 50 mg/m2 weekly over 1 hour; carboplatin at (area under the curve) AUC 2 weekly; and radiation therapy of 66 Gy in 33 fractions. After chemoradiation therapy, patients received an additional two cycles of paclitaxel 200 mg/m2 over 3 hours and carboplatin at AUC 6 every 3 weeks. RESULTS Thirty-nine patients were eligible for the study. The survival rates at 12 months were 56.3%, and at 24 months, 38.3%, with a median overall survival of 20.5 months. The progression-free survival rates at 12 months were 43.6%, and at 24 months, 34.7%, with a median progression-free survival of 9.0 months. Two patients did not receive more than 2 weeks of concurrent chemoradiotherapy and were not assessable for toxicity and response. The overall response rate (partial plus complete response) of 37 assessable patients was 75.7%. The major toxicity was esophagitis. Seventeen patients (46%) developed grade 3 or 4 esophagitis. However, only two patients developed late esophageal toxicity with stricture at 3 and 6 months posttreatment. CONCLUSION Combined modality therapy with paclitaxel, carboplatin, and radiation is a promising treatment for locally advanced NSCLC that has a high response rate and acceptable toxicity and survival rates. A randomized trial will be necessary to fully evaluate the usefulness of these findings.

Intensity-modulated radiation therapy (IMRT) in patients with locally advanced pancreatic cancer (LAPC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 377-377 ◽  
Author(s):  
Carla Hajj ◽  
Florence Huguet ◽  
Abraham Jing-Ching Wu ◽  
Eileen Mary O'Reilly ◽  
Corinne Winston ◽  
...  
Keyword(s):  
Local Control ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Positive Margin ◽  
Surgical Patients ◽  
Hematologic Toxicity ◽  
Free Survival ◽  
Local Progression

377 Background: To assess IMRT safety and evaluate local control and resectability among patients with LAPC treated with induction CT followed by IMRT. Methods: We reviewed records of 134 LAPC patients treated with CT (median duration 3.2 months) followed by IMRT (median dose 56 Gy) between 11/2006 and 11/2012. Patients had LAPC based on T4 disease or unreconstructable involvement of portal vein/hepatic artery on imaging (n=102) or were found to be unresectable after an attempted resection (n=32). Induction CT was gemcitabine-based (n=98) or FOLFIRINOX (n=32); concurrent CT was gemcitabine in 88 patients, continuous 5-FU or capecitabine in 37 patients. IMRT was given after induction CT in the absence of evidence of disease progression. After IMRT, 81 patients received maintenance CT. Results: Acute grade 3 GI and hematologic toxicity were seen in 4 (2.9%) and 33 (24.6%) patients, respectively. Acute grade 4 GI and hematologic toxicity were seen in 0 and 5 (3.7%) patients, respectively. Ten patients (7.4%) developed late grade 1 GI toxicity and 2 patients (0.7%) developed compression fractures. Twenty-six (19.4%) patients underwent resection 4.1 months (mean) after IMRT; 22 (84.6%) had negative margins, one of whom had a pathologic complete response and 4 had a microscopically positive margin. With 20.1 months median f-up, median local progression-free survival (LPFS) was 17.6 months. One- and 2-year LPFS were 90% and 55% respectively. Median distant metastasis free survival (DMFS) was 15.2 months. One- and 2-year DMFS were 69.5% and 30.7% respectively. Median OS was 19.7 months for the whole population (24.8 months for surgical patients and 19.7 months for the non-surgical patients). One- and 2-year OS for all patients were 85% and 47% respectively; one- and 2-year OS for the surgical patients were 96% and 72% respectively. Conclusions: In this large cohort of patients treated with IMRT for LAPC, acute and late toxicity was minimal. Patients with non-progressive LAPC after induction CT who received IMRT had high rates of local control which could translate into a better quality of life. In selected patients, induction CT followed by IMRT can downstage tumors allowing for R0 resections and improved overall survival.

Long-Term Survival Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin, With Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in Patients With Bladder Cancer

2005 ◽  
Vol 23 (21) ◽  
pp. 4602-4608 ◽  
Author(s):  
Hans von der Maase ◽  
Lisa Sengelov ◽  
James T. Roberts ◽  
Sergio Ricci ◽  
Luigi Dogliotti ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Term Survival ◽  
Free Survival ◽  
Visceral Metastases ◽  
Overall Survival Rates

Purpose To compare long-term survival in patients with locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium treated with gemcitabine/cisplatin (GC) or methotrexate/vinblastine/doxorubicin/cisplatin (MVAC). Patients and Methods Efficacy data from a large randomized phase III study of GC versus MVAC were updated. Time-to-event analyses were performed on the observed distributions of overall and progression-free survival. Results A total of 405 patients were randomly assigned: 203 to the GC arm and 202 to the MVAC arm. At the time of analysis, 347 patients had died (GC arm, 176 patients; MVAC arm, 171 patients). Overall survival was similar in both arms (hazard ratio [HR], 1.09; 95% CI, 0.88 to 1.34; P = .66) with a median survival of 14.0 months for GC and 15.2 months for MVAC. The 5-year overall survival rates were 13.0% and 15.3%, respectively (P = .53). The median progression-free survival was 7.7 months for GC and 8.3 months for MVAC, with an HR of 1.09. The 5-year progression-free survival rates were 9.8% and 11.3%, respectively (P = .63). Significant prognostic factors favoring overall survival included performance score (> 70), TNM staging (M0 v M1), low/normal alkaline phosphatase level, number of disease sites (≤ three), and the absence of visceral metastases. By adjusting for these prognostic factors, the HR was 0.99 for overall survival and 1.01 for progression-free survival. The 5-year overall survival rates for patients with and without visceral metastases were 6.8% and 20.9%, respectively. Conclusion Long-term overall and progression-free survival after treatment with GC or MVAC are similar. These results strengthen the role of GC as a standard of care in patients with locally advanced or metastatic TCC.

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