scholarly journals Robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open esophagectomy: long-term follow-up of a randomized clinical trial

2020 ◽  
Vol 33 (Supplement_2) ◽  
Author(s):  
Eline M de Groot ◽  
Sylvia van der Horst ◽  
B Feike Kingma ◽  
Lucas Goense ◽  
Pieter C van der Sluis ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Free Survival ◽  
Rank Test ◽  
Robot Assisted ◽  
Short Term ◽  
Free Survival ◽  
Log Rank Test ◽  
Disease Free

ABSTRACT Initial results of the ROBOT, which randomized between robot-assisted minimally invasive esophagectomy (RAMIE) and open transthoracic esophagectomy (OTE), showed significantly better short-term postoperative outcomes in favor of RAMIE. However, it is not yet clarified if RAMIE is equivalent to OTE regarding long-term outcomes. The aim of this study was to report the long-term oncological results of the ROBOT trial in terms of survival and disease-free survival. This study is a follow-up study of the ROBOT trial, which was a randomized controlled trial comparing RAMIE to OTE in 112 patients with intrathoracic esophageal cancer. Both the trial protocol and short-term results were previously published. The primary outcome of the current study was 5-year overall survival. Secondary outcomes were disease-free survival and recurrence patterns. Analysis was by intention to treat. During the recruitment period, 109 patients were included in the survival analysis (RAMIE n = 54, OTE n = 55). Majority of patients had clinical stage III or IV (RAMIE 63%, OTE 55%) and received neoadjuvant chemoradiotherapy (80%). Median follow-up was 60 months (range 31–60). The combined 5-year overall survival rates for RAMIE and OTE were 41% (95% CI 27–55) and 40% (95% CI 26–53), respectively (log rank test P = 0.827). The 5-year disease-free survival rate was 42% (95% CI 28–55) in the RAMIE group and 43% (95% CI 29–57) in the OTE group (log rank test P = 0.749). Out of 104 patients, 57 (55%) developed recurrent disease detected at a median of 10 months (range 0–56) after surgery. No statistically difference in recurrence rate nor recurrence pattern was observed between both groups. Overall survival and disease-free survival of RAMIE are comparable to OTE. These results continue to support the use of robotic surgery for esophageal cancer.

Burden of lymphatic disease predicts efficacy of adjuvant radiation and chemotherapy in FIGO 2018 stage IIICp cervical cancer

2019 ◽  
Vol 29 (9) ◽  
pp. 1355-1360 ◽  
Author(s):  
Giorgio Bogani ◽  
Daniele Vinti ◽  
Ferdinando Murgia ◽  
Valentina Chiappa ◽  
Umberto Leone Roberti Maggiore ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Rank Test ◽  
Survival Outcomes ◽  
Adjuvant Radiation ◽  
Free Survival ◽  
Log Rank Test ◽  
Disease Free ◽  
Positive Lymph Nodes

ObjectiveNodal involvement is one of the most important prognostic factors in cervical cancer patients. We aimed to assess the prognostic role in relation to the burden of nodal disease in stage IIICp cervical cancer.MethodsData on all consecutive patients diagnosed with cervical cancer undergoing primary surgery (radical hysterectomy plus lymphadenectomy) or neoadjuvant chemotherapy followed by radical hysterectomy plus lymphadenectomy, between January 1980 and December 2017, were collected in a dedicated database. Exclusion criteria were: (1) consent withdrawal; (2) synchronous malignancies (within 5 years). Survival outcomes were assessed using Kaplan-Meier and Cox models.ResultsOverall, 177 (14.1%) of 1257 patients with cervical cancer were diagnosed with positive lymph nodes. After a median follow-up of 58 (range 4–175) months, 66 (37.3%) and 37 (20.9%) patients developed recurrent disease and died of disease, respectively. Via multivariate analysis, positive para-aortic nodes (HR 2.62, 95% CI 1.12 to 6.11; p=0.025) and the number of positive nodes (HR 1.06, 95% CI 1.02 to 1.11; p=0.002) correlated with worse disease-free survival. Furthermore, the number of positive nodes (HR 1.06, 95% CI 1.01 to 1.12; p=0.021) correlated with worse overall survival. Number of positive nodes (1, 2 or ≥3) strongly correlated with both disease-free survival (p<0.001, log-rank test) and overall survival (p=0.001, log-rank test). Focusing on patients receiving adjuvant radiation and chemotherapy, the number of positive lymph nodes was associated with response to treatment (p<0.001). Median disease-free survival was 100, 42, and 12 months for patients with one, two, or three or more positive lymph node(s), respectively (p<0.001, log-rank test).ConclusionsIn stage IIICp cervical cancer, adjuvant radiation and chemotherapy provides adequate overall survival in patients diagnosed with only one metastatic node, while survival outcomes are poor in patients with two or more metastatic nodes. This highlights the need for innovative treatments in patients with a high burden of lymphatic disease.

5-Year Results of Dose-Intensive Sequential Adjuvant Chemotherapy for Women With High-Risk Node-Positive Breast Cancer: A Phase II Study

1999 ◽  
Vol 17 (4) ◽  
pp. 1118-1118 ◽  
Author(s):  
C. Hudis ◽  
M. Fornier ◽  
L. Riccio ◽  
D. Lebwohl ◽  
J. Crown ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Pilot Study ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Dose Dense ◽  
Disease Free

PURPOSE: We conducted a phase II pilot study of dose-intensive adjuvant chemotherapy with doxorubicin followed sequentially by high-dose cyclophosphamide to determine the safety and feasibility of this dose-dense treatment and to estimate the disease-free and overall survival in breast cancer patients with four or more involved axillary lymph nodes. PATIENTS AND METHODS: Seventy-three patients received adjuvant treatment with four cycles of doxorubicin 75 mg/m2 as an intravenous bolus every 21 days, followed by three cycles of cyclophosphamide 3,000 mg/m2 every 14 days with granulocyte colony-stimulating factor support. RESULTS: Seventy-one patients were assessable, and all but two completed all planned chemotherapy. There was no treatment-related mortality. The most common toxicity was neutropenic fever, which occurred in 39% of patients. Median disease-free survival is 66 months (95% confidence interval, 34 to 98 months), and median overall survival has not yet been reached. At 5 years of follow-up, the disease-free survival is 51.7%, and overall survival is 60.0%. There is no long-term treatment-related toxicity, and no cases of acute myelogenous leukemia or myelodysplastic syndrome have been observed. CONCLUSION: Our pilot study of doxorubicin followed by cyclophosphamide demonstrates the safety and feasibility of the sequential dose-dense plan. Long-term follow-up, although noncomparative, is promising. However, this regimen is associated with a higher incidence of toxicity (and also higher costs) than the standard dose and schedule of doxorubicin and cyclophosphamide, and therefore it should not be used as conventional therapy in the absence of demonstrated improvement of outcome. Randomized trials testing the dose-dense approach have been completed but not yet reported. Because the sequential plan can decrease overlapping toxicities, it is an appropriate platform for the addition of newer active agents, such as taxanes or monoclonal antibodies.

Comparison of long-term outcome between endoscopic submucosal dissection and surgical resection for early gastric cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 144-144
Author(s):  
Boo Gyeong Kim ◽  
Byung-Wook Kim ◽  
Joon Sung Kim ◽  
Sung Min Park ◽  
Keun Joon Lim ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Rate ◽  
Surgical Resection ◽  
Disease Free Survival ◽  
Overall Survival Rate ◽  
Free Survival ◽  
Resection Group ◽  
Disease Free

144 Background: The aim of this study is to evaluate the long-term clinical and oncologic outcome of ESD for differentiated EGC of an expanded indication compared to surgical resection. Methods: Retrospective analyses were performed in patients who underwent ESD or surgical resection for EGC of an expanded indication from 2006 and 2008 in Incheon St. Mary’s Hospital, Seoul St. Mary’s Hospital, Yeouido St. Mary’s Hospital, and St. Paul’s Hospital. First arm study was performed according to pre-ESD diagnosis including pathologic diagnosis and endoscopic findings. Second arm study was obtained from post-ESD final pathologic result. All the patients were checked with endoscopy and stomach CT regularly at least 5 years. Clinical outcomes, disease free survival and overall survival were compared between the ESD group and surgical resection group in each arm. Results: In first arm study, 41 patients who received ESD and 106 patients who received surgical resection were enrolled. Metachronous recur was found in 4 patients among ESD group and in 2 patients among surgical resection group during the follow up period. There was no local recurrence in both groups. The disease free survival was not different between the two groups (ESD vs surgical resection; 87.8 vs 95.3%, p=0.291). The 5-year overall survival rate was 100% in both groups. In second arm study, 74 patients who received ESD and 165 patients who received surgical resection were enrolled. Metachronous recur was found in 5 patients among ESD group and in 2 patients among surgical resection group during the follow up period. Local recurrence did not occur in both groups. Surgical resection group was superior to ESD group in disease free survival (97.6% vs 87.6%, p=0.002). The 5-year overall survival rate was 100% in both groups. Conclusions: ESD for EGC might be acceptable considering the overall survival rates. However, intensive surveillance should be performed to find the metachronous recur after ESD.

scholarly journals Long-term and short-term outcomes of robot- versus video-assisted anatomic lung resection in lung cancer: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Han Wu ◽  
Runsen Jin ◽  
Su Yang ◽  
Bernard J Park ◽  
Hecheng Li
Keyword(s):  
Overall Survival ◽  
Thoracic Surgery ◽  
Open Surgery ◽  
Lung Resection ◽  
Disease Free Survival ◽  
Short Term ◽  
Free Survival ◽  
Anatomic Lung Resection ◽  
Disease Free

Abstract OBJECTIVES Minimally invasive thoracic surgery has evolved with the introduction of robotic platforms. This study aimed to compare the long-term and short-term outcomes of the robot-assisted thoracic surgery (RATS) and video-assisted thoracic surgery (VATS) for anatomic lung resection. METHODS We searched published studies that investigated RATS and VATS in anatomic lung resection. Long-term outcomes (disease-free survival and overall survival) and short-term outcomes (30-day mortality, postoperative complications, conversion rate to open surgery and lymph node upstaging) were extracted. The features were compared and tested as hazard ratios (HRs) and odds ratios (ORs) at a 95% confidence interval (CI). RESULTS Twenty-five studies with 50 404 patients (7135 for RATS and 43 269 for VATS) were included. The RATS group had a longer disease-free survival than the VATS group (HR: 0.76; 95% CI: 0.59–0.97; P = 0.03), and the overall survival showed a similar trend but was not statistically significant (HR: 0.77; 95% CI: 0.57–1.05; P = 0.10). The RATS group showed a significantly lower 30-day mortality (OR: 0.55; 95% CI: 0.38–0.81; P = 0.002). No significant difference was found in postoperative complications (OR: 1.01; 95% CI: 0.87–1.16; P = 0.94), the conversion rate to open surgery (OR: 0.92; 95% CI: 0.56–1.52; P = 0.75) and lymph node upstaging (OR: 0.89; 95% CI: 0.52–1.54; P = 0.68). CONCLUSIONS RATS has comparable short-term outcomes and potential long-term survival benefits for anatomic lung resection compared with VATS.

scholarly journals Survival outcomes of adjuvant taxanes, platinum plus fluoropyrimidines versus platinum and fluoropyrimidines for gastric cancer patients after D2 gastrectomy: a retrospective propensity score-matched analysis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Lili Wu ◽  
Ying Feng ◽  
Zhijun Wu ◽  
Hui Xu ◽  
Cheng Zhang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Propensity Score ◽  
Disease Free Survival ◽  
Rank Test ◽  
Free Survival ◽  
D2 Gastrectomy ◽  
Log Rank Test ◽  
Baseline Characteristics ◽  
Gastric Cancer Patients ◽  
Disease Free

Abstract Background To evaluate whether the addition of taxanes to platinum and fluoropyrimidines in adjuvant chemotherapy would result in longer survival than platinum plus fluoropyrimidines in gastric cancer patients who received D2 gastrectomy. Methods Data of patients with gastric adenocarcinoma who received D2 gastrectomy and adjuvant chemotherapy with platinum plus fluoropyrimidines or taxanes, platinum plus fluoropyrimidines was retrospectively collected and analyzed. 1:1 Propensity score matching analysis was used to balance baseline characteristics between two groups. Survival curves were estimated using Kaplan-Meier method, and the differences were compared using the log-rank test. Results Four hundred twenty-five patients in the platinum plus fluoropyrimidines group and 177 patients in the taxanes, platinum plus fluoropyrimidines group were included into analysis. No statistical differences in disease-free survival and overall survival were observed between two groups. After propensity score matching, 172 couples of patients were matched, the baseline characteristics were balanced. The median disease-free survival were 15.8 months (95% CI, 9.3~22.4) in the platinum plus fluoropyrimidines group and 22.6 months (95% CI, 15.9~29.4) in the taxanes, platinum plus fluoropyrimidines group (HR = 0.63; 95% CI, 0.48~0.85; P = 0.002). The median overall survival was 25.4 months for patients in the platinum plus fluoropyrimidines group (95% CI, 19.4~31.3) and 33.8 months (95% CI, 23.5~44.2) for those in the taxanes, platinum plus fluoropyrimidines group (HR = 0.68; 95% CI, 0.53-0.87; log-rank test, P = 0.002). Conclusions For gastric adenocarcinoma patients, the adjuvant triplet combination of taxanes, platinum, and fluoropyrimidines regimen after D2 gastrectomy was superior to platinum plus fluoropyrimidines regimen in disease-free survival as well as overall survival. Trial registration This project has been registered in the Chinese Clinical Trial Registry (ChiCTR1800019978).

scholarly journals Faktor yang Berpengaruh Terhadap Disease Free Survival dan Overall Survival pada Pasien Kanker Payudara Usia Muda di Kota Padang Tahun 2008 - 2018

2020 ◽  
Vol 9 (1S) ◽  
Author(s):  
Magdi Ayuza ◽  
Wirsma Arif Harahap ◽  
Rony Rustam ◽  
Richvan Dana Nindrea
Keyword(s):  
Overall Survival ◽  
Cohort Study ◽  
Disease Free Survival ◽  
Rank Test ◽  
Free Survival ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Disease Free ◽  
Data Register

Kanker Payudara (KPD) pada usia muda memiliki keistimewaan karakteristik. Rekurensi KPD dipengaruhi oleh berbagai faktor antara lain faktor klinis, regimen terapi dan biomolekuler dari tumor itu sendiri. Berbagai macam modalitas terapi KPD, namun masih terdapat risiko terjadinya rekurensi terutama pada pasien dewasa muda. Tujuan: Mengetahui faktor-faktor yang mempengaruhi Disease Free Survival (DFS) dan Overall Survival (OS) pada pasien KPD usia muda di Kota Padang. Metode: Penelitian ini menggunakan desain cohort study retrospectif pada pasien KPD usia muda yang telah mendapatkan pengobatan KPD yang memenuhi kriteria inklusi sebanyak 103 sample yang terdapat pada data register KPD PERABOI Padang. Analisis survival menggunakan Kaplan Meier dengan Log Rank Test. Apabila diperoleh nilai p < 0,05, maka terdapat hubungan bermakna. Hasil: Terdapat perbedaan antara setiap faktor klinis, faktor biomolekuler dan faktor terapi dalam hal rata-rata DFS maupun rata-rata OS, namun tidak terdapat pengaruh yang bermakna secara analisis statistik antara faktor terapi (terapi hormon, radioterapi dan terapi target) terhadap DFS dan OS pada pasien kanker payudara usia muda di Kota Padang (p>0,05). Terdapat pengaruh dari pemberian kemoterapi terhadap DFS pada pasien kanker payudara usia muda di Kota Padang (p<0,05). Simpulan: Tidak terdapat hubungan yang bermakna antara faktor klinis dan faktor biomolekuler dengan DFS dan OS, namun terdapat hubungan bermakna antara pemberian kemoterapi dengan DFS dan OS pada penderita KPD usia muda di kota Padang tahun 2008 – 2018.

Tamoxifen Adjuvant Treatment Duration in Early Breast Cancer: Initial Results of a Randomized Study Comparing Short-Term Treatment With Long-Term Treatment

2000 ◽  
Vol 18 (20) ◽  
pp. 3507-3512 ◽  
Author(s):  
Thierry Delozier ◽  
Marc Spielmann ◽  
Josette Macé-Lesec’h ◽  
Maud Janvier ◽  
Catherine Hill ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Free Survival ◽  
Term Treatment ◽  
Tamoxifen Treatment ◽  
Adjuvant Tamoxifen ◽  
Short Term ◽  
Free Survival ◽  
Long Term Treatment ◽  
Disease Free

PURPOSE: In 1986, The Fédération Nationale des Centres de Lutte Contre le Cancer Breast Group initiated a multicenter randomized trial to assess the usefulness of long-term adjuvant tamoxifen treatment. Short-term adjuvant tamoxifen treatment was to be compared with lifelong adjuvant tamoxifen treatment. PATIENTS AND METHODS: Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen treatment were eligible for the trial. From September 1986 to May 1995, 3,793 patients were randomized from France, Belgium, and Argentina. A total of 1,882 patients stopped tamoxifen (short-term group), and 1,911 patients were to continue tamoxifen for life (long-term group) at the same dose as previously prescribed. The protocol was modified in February 1997, limiting tamoxifen treatment to 10 years after randomization, thus giving a comparison between a 2- to 3-year treatment and a 12- to 13-year treatment. To date, the median duration of tamoxifen treatment is 30 months in the short-term group, and 70 months in the long-term group. RESULTS: Overall, longer tamoxifen treatment induced a 23% reduction in relapse rates, leading to a 7-year disease-free survival rate of 78%, compared with 72% in the shorter-treatment group. In contrast, overall survival did not differ between the two groups, with a 79% overall survival rate in both groups. This improvement in disease-free survival could be observed in node-positive patients (P = .001); however, it was not found in node-negative patients. Prolonged tamoxifen treatment corresponded to a significant increase in disease-free survival in estrogen receptor–positive patients (P = .03) as well as in estrogen receptor–negative patients (P = .05). Furthermore, longer treatment reduced contralateral breast cancers and did not increase the number of endometrial cancers. CONCLUSION: : Although no survival advantage was noted, patients did benefit from longer tamoxifen treatment over 3 years and had significantly better disease-free survival compared with patients who stopped hormonal treatment. Long-term follow-up is needed to assess these results. Most patients in the long-term group are still receiving treatment. Comparison of results as time passes will enable conclusions to be made on the value of long-term treatment over 5 years compared with 2 to 3 years.

Long-Term Results of the International Adjuvant Lung Cancer Trial Evaluating Adjuvant Cisplatin-Based Chemotherapy in Resected Lung Cancer

2010 ◽  
Vol 28 (1) ◽  
pp. 35-42 ◽  
Author(s):  
Rodrigo Arriagada ◽  
Ariane Dunant ◽  
Jean-Pierre Pignon ◽  
Bengt Bergman ◽  
Mariusz Chabowski ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Long Term Results ◽  
Cancer Trial ◽  
Free Survival ◽  
Disease Free

Purpose Based on 5-year or shorter-term follow-up data in recent randomized trials, adjuvant cisplatin-based chemotherapy is now generally recommended after complete surgical resection for patients with non–small-cell lung cancer (NSCLC). We evaluated the results of the International Adjuvant Lung Cancer Trial study with three additional years of follow-up. Patients and Methods Patients with completely resected NSCLC were randomly assigned to three or four cycles of cisplatin-based chemotherapy or to observation. Cox models were used to evaluate treatment effect according to follow-up duration. Results The trial included 1,867 patients with a median follow-up of 7.5 years. Results showed a beneficial effect of adjuvant chemotherapy on overall survival (hazard ratio [HR], 0.91; 95% CI, 0.81 to 1.02; P = .10) and on disease-free survival (HR, 0.88; 95% CI, 0.78 to 0.98; P = .02). However, there was a significant difference between the results of overall survival before and after 5 years of follow-up (HR, 0.86; 95% CI, 0.76 to 0.97; P = .01 v HR, 1.45; 95% CI, 1.02 to 2.07; P = .04) with P = .006 for interaction. Similar results were observed for disease-free survival. The analysis of non-lung cancer deaths for the whole period showed an HR of 1.34 (95% CI, 0.99 to 1.81; P = .06). Conclusion These results confirm the significant efficacy of adjuvant chemotherapy at 5 years. The difference in results beyond 5 years of follow-up underscores the need for the long-term follow-up of other adjuvant lung cancer trials and for a better identification of patients deriving long-term benefit from adjuvant chemotherapy.

scholarly journals O20: PREOPERATIVE INTRAVENOUS IRON THERAPY AND SURVIVAL AFTER COLORECTAL CANCER SURGERY: LONG TERM RESULTS FROM THE INTRAVENOUS IRON IN COLORECTAL CANCER-ASSOCIATED ANAEMIA (IVICA) TRIAL

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
EA Dickson ◽  
BD Keeler ◽  
O Ng ◽  
A Kumar ◽  
MJ Brookes ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Intravenous Iron ◽  
Cancer Surgery ◽  
Colorectal Cancer Surgery ◽  
Free Survival ◽  
Disease Free

Abstract Background Intravenous iron is now the standard treatment to correct preoperative anaemia. However, iron may promote tumour growth and progression which could influence cancer recurrence and survival. We explore the long term postoperative outcomes of patients receiving oral (OI) or intravenous iron (IVI) as part of a randomised controlled trial. Method The multicentre IVICA trial randomised anaemic colorectal cancer patients in a 1:1 fashion to receive either OI or IVI prior to their elective operation. Follow up analysis of all patients was performed and Kaplan-Meier survival estimates and Cox proportional hazard models were used to compare groups. A pooled analysis comparing patients who did/did not achieve preoperative resolution of anaemia was also undertaken. Result, Data were available for 106 of the 116 IVICA patients (OI n=55, IVI n=51). Median follow up was 61 months (IQR 38-68, [range 1-80]). Overall survival estimates at 3 and 5 years were 82%(95% CI 76-90) and 72%(58-83) respectively for OI and 75%(61-86) and 59%(45-72) for IVI, P=0.106. No significant difference in 5-year overall survival (HR 1.73, 95% CI 0.90-3.34 P=0.102) or disease-free survival (HR 1.50, 95% CI 0.83-2.73 P=0.182) was observed between groups. Those non-anaemic at operation demonstrated improved 5 year overall survival (HR 3.26 [1.01-10.58], P=0.05). Non-significant trends in improved disease-free survival (HR 2.29 [0.91-5.81], p=0.08) were observed for the non-anaemic group Conclusion Preoperative correction of anaemia confers a postoperative survival advantage following elective colorectal cancer surgery. Due to its superior efficacy intravenous iron is recommended as the treatment of choice for this anaemia. Take-home message Preoperative correction of anaemia, achieved most effectively with intravenous iron, may offer improved long term postoperative survival after colorectal cancer surgery.

scholarly journals Rituximab Maintenance Treatment for a Maximum of 5 Years in Follicular Lymphoma: Final Results of the Randomized Phase III Trial SAKK 35/03

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1601-1601 ◽  
Author(s):  
Christian Taverna ◽  
Giovanni Martinelli ◽  
Felicitas Hitz ◽  
Walter Mingrone ◽  
Thomas Pabst ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Phase Iii ◽  
Rank Test ◽  
Short Term ◽  
Free Survival ◽  
Rituximab Maintenance ◽  
Log Rank Test ◽  
Term Maintenance

Abstract Background: Follicular lymphoma is usually a disase with a prolonged course and a chemotherapy-free regimen might be a favourable treatment strategy. SAKK 35/03 investigated two different durations of rituximab maintenance (5 years vs. 6 months) in patients with follicular lymphoma after induction with 4 weekly doses of rituximab monotherapy. With a median follow-up of 6.4 years we were not able to show a benefit with long-term rituximab maintenance up to five years in event-free survival (EFS) or overall survival (OS ). Here we report the final results with a median follow-up of 10 years. Methods: 270 patients (median age 57 years: range 25-82) with untreated, relapsed, stable or chemotherapy resistant follicular lymphoma were treated with 4 doses of rituximab monotherapy in weekly intervals (375 mg/m²). Patients achieving at least a partial response were randomly assigned to receive maintenance therapy with one infusion of rituximab every 2 months, either on a short-term schedule (four administrations) or a long-term schedule (maximum of five years or until disease progression or unacceptable toxicity). The primary endpoint was EFS . Progression-free survival (PFS), OS, and toxicity were secondary endpoints. Comparisons between the two treatment arms were performed using the log-rank test for survival endpoints. Results: 165 patients were randomly assigned to short-term (n=82) or long-term (n=83) maintenance. At a median follow-up period of 10 years, the median EFS is 3.4 years (95% CI 2.1-5.5) in the short-term arm and 5.3 years (95% CI 3.5-7.5) in the long-term arm. Using the pre-specified log-rank test this difference is statistically not significant (p=0.39 ). There is no significant difference in PFS and OS. Median OS in the short-term arm is 11.0 years (95% CI 11.0, NA ) and not reached in the long-term arm (p=0.80). The incidence of subsequent cancers increased in both arms over time, nine patients developed a subsequent cancer in the short-term maintenance arm and 10 in the long-term maintenance arm. There was no major additional toxicity with longer follow-up. Conclusions : Even with a long follow-up of 10 years we were not able to show a significant benefit of long-term compared to short-term rituximab maintenance in EFS, PFS and OS. Treatment strategies and study designs need to take these results into consideration in order to guarantee optimal medical and scientific results. Disclosures Zucca: Celltrion: Consultancy; AstraZeneca: Consultancy. Ghielmini:Roche: Consultancy, Honoraria, Research Funding, Speakers Bureau.

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