Faculty Opinions recommendation of Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients.

Abstract Abstract 5115 INTRODUCTION. Even with the introduction of novel therapeutic agents, including thalidomide, bortezomib, and lenalidomide, multiple myeloma (MM) is an incurable disease. Deeper responses, such as complete response (CR) and very good partial response (VGPR), are major goals of treatment to obtain long-term overall response (OS) and progression-free response (PSF) in patients with MM. Recent large randomized retrospective studies also suggested improved OS and PFS in patients who achieved deeper responses. However, the prognostic impact of achieving CR or VGPR remains controversial. In addition, these studies included selected patients that may not be representative of the general population. Therefore, we analyzed cases in our database to evaluate the impact of treatment response on the outcome of consecutive patients with symptomatic MM who were treated with chemotherapeutic regimens containing novel agents over the past 6 years at our institution in Kamogawa City, Japan. PATIENTS AND METHODS. We included 97 consecutive patients treated at our institution between April 2005 and May 2011. The study population consisted of 56 male and 41 female patients with a median age of 70 years old (range: 45 −90). Due to the rapid changes in treatment modality and government approval of novel agents in myeloma during this period, initial treatment could not be uniformly categorized, but all patients received chemotherapy regimens containing at least one novel agent, including thalidomide, bortezomib, and lenalidomide. These patients were thought to be more representative of the general myeloma population. Seventy-seven (79.4%), 27 (38.6%), and 55 (56.7%) patients received bortezomib-, lenalidomide-, and thalidomide-containing regimens, respectively. Treatment responses were assessed using the International Myeloma Working Group (IMWG) criteria with minor modifications, and the best response to treatment during the course of disease was evaluated. Immunofixation test and serum free light chain measurements were performed for confirmation of CR and stringent CR. OS was calculated from the time of diagnosis until the date of death from any cause or the date on which the patient was last known to be alive. Univariate and multivariate analyses were performed for the following variables: age at diagnosis, International Staging System (ISS), and best response achieved. RESULT. The median age of patients was 71 y.o. (range: 49 −90 y.o.), and the male to female ratio was 56:41. The best responses to treatment were as follows: CR was obtained in 19 cases (19.6%), VGPR in 29 (29.9%), partial response (PR) in 34 (35.0%), and stable disease (SD) or less in 15 (15.4%). Baseline characteristics according to best response achieved in patients who achieved CR, VGPR, PR, and SD or less were similar among the patients ≥70 y.o. vs. ≤70 y.o. Patients' age has no impact on the response to treatment. With a median follow-up of 25 months, Kaplan–Meier estimated 3-year and 5-year overall survival (OS) rates were 67.2% and 35.0%, respectively. The 3- and 5-year OS were 100% in patients with CR, which were significantly superior in patients with VGPR (3-y 70%, 5-y 55.0%) and PR (3-y 60%, 5-y 23.0%). The 3- and 5-year OS were not significantly different between patients with VGPR and PR. Normalization of FLC kappa/Lambda ratio was observed in 15 of 19 (80%) patients with CR, 15 of 29 (51%) with VGPR, 4 of 34 (6.6%) in PR, and in none of 15 (0%) in SD or less. Patients who showed normalization of FLC kappa/Lambda ratio had significant OS benefit compared to those who did not. Proportional hazard Cox models showed that patients with ISS stage I/II had better 5-year OS rate compared to patients with stage III (51%; 20%, P = 0.005). However, there was no association between ISS stage and achievement of CR. CONCLUSION. The results of the present study highlighted the importance of achieving CR, not PR or VGPR, and normalization of FLC kappa/Lambda ratio for obtaining long-term OS in patients with MM regardless of age or ISS stage. Disclosures: No relevant conflicts of interest to declare.

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Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients

Blood ◽

10.1182/blood-2010-09-307645 ◽

2011 ◽

Vol 117 (11) ◽

pp. 3025-3031 ◽

Cited By ~ 178

Author(s):

Francesca Gay ◽

Alessandra Larocca ◽

Pierre Wijermans ◽

Federica Cavallo ◽

Davide Rossi ◽

...

Keyword(s):

Overall Survival ◽

Progression Free Survival ◽

Complete Response ◽

Hazard Ratio ◽

Novel Agents ◽

Maximal Response ◽

Term Outcome ◽

Long Term Outcome ◽

The Impact

AbstractComplete response (CR) was an uncommon event in elderly myeloma patients until novel agents were combined with standard oral melphalan-prednisone. This analysis assesses the impact of treatment response on progression-free survival (PFS) and overall survival (OS). We retrospectively analyzed 1175 newly diagnosed myeloma patients, enrolled in 3 multicenter trials, treated with melphalan-prednisone alone (n = 332), melphalan-prednisone-thalidomide (n = 332), melphalan-prednisone-bortezomib (n = 257), or melphalan-prednisone-bortezomib-thalidomide (n = 254). After a median follow-up of 29 months, the 3-year PFS and OS were 67% and 27% (hazard ratio = 0.16; P < .001), and 91% and 70% (hazard ratio = 0.15; P < .001) in patients who obtained CR and in those who achieved very good partial response, respectively. Similar results were observed in patients older than 75 years. Multivariate analysis confirmed that the achievement of CR was an independent predictor of longer PFS and OS, regardless of age, International Staging System stage, and treatment. These findings highlight a significant association between the achievement of CR and long-term outcome, and support the use of novel agents to achieve maximal response in elderly patients, including those more than 75 years. This trial was registered at www.clinicaltrials.gov as #NCT00232934, #ISRCTN 90692740, and #NCT01063179.

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Long-Term Disease Control in Patients with Primary Central Nervous System Lymphoma

Blood ◽

10.1182/blood.v112.11.3600.3600 ◽

2008 ◽

Vol 112 (11) ◽

pp. 3600-3600

Author(s):

Ingo Schmidt-Wolf ◽

Hendrik Pels ◽

Annika Jürgens ◽

Sabine Rogowski ◽

Axel Glasmacher ◽

...

Keyword(s):

Overall Survival ◽

Central Nervous System Lymphoma ◽

Response Duration ◽

Complete Response ◽

High Dose ◽

Survival Fraction ◽

Median Response ◽

Kaplan Meier ◽

Time To Treatment Failure

Abstract Objectives: A pilot phase II trial was performed to evaluate response rate, response duration, overall survival, and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intraventricular chemotherapy with deferred radiotherapy. Patients and Methods: From 09/1995 to 12/2002, 65 patients with PCNSL (median age 62 years) were enrolled into a pilot/phase II study evaluating chemotherapy without radiotherapy. A high-dose methotrexate (MTX) (cycles 1,2,4,5) and cytarabine (ara-C) (cycles 3,6) based systemic therapy (including dexamethasone, vinca-alkaloids, ifosfamide and cyclophosphamide) was combined with intraventricular MTX, prednisolone and ara-C. Primary endpoint was time to treatment failure (TTF), secondary endpoints were response, overall survival, response duration, 5-year-survival fraction and (neuro)toxicity. Results: 34 patients were male, 31 female. Sixty-one of 65 patients were evaluable for response. Of these, 37 (61%) achieved a complete response (CR), 6 (10%) complete response/unconfirmed, and 12 (20%) progressed under therapy. Overall response rate was 71% for all patients and 86% for patients younger than 61 years. Six (9%) out of 65 patients died due to treatment-related complications. Follow-up time is 78 to 151 months in surviving patients (median 100 months). Kaplan Meier estimates for median time to treatment failure (TTF), median overall survival and median response duration are 22 months, 54 months and 37 months, respectively. For patients aged 60 years or older, the respective numbers were 7 months, 34 months and 30 months; in patients younger than 60 years, the Kaplan Meier estimate for TTF is 49 months, median overall survival and median response duration have not yet been reached. The 5-year survival fraction is 72% in patients < 60 years and 24% in older patients. Systemic toxicity was mainly hematologic. Ommaya reservoir infection occurred in 19% of the patients. At present, 17/30 (57%) of younger and 4/35 (9%) elderly patients are still alive. Only 5/30 (17%) of younger, but 19/35 (54%) of elderly patients received radiation salvage therapy at relapse. In 2/65 (3%), secondary cancers developed. In the subgroup of patients with long-term survival (n=17/30 under 61 years), 12 had an ongoing response, 1 an isolated CNS relapse (resolved by radiation), 1 an isolated ocular relapse (resolved by ocular radiation) and 3 a pure systemic relapse without CNS involvement (all resolved by systemic chemotherapy). Eleven of these 17 patients could be investigated by comprehensive neuropsychological testing, which revealed normal cognitive function in all of them. Conclusions: Primary chemotherapy based on high-dose MTX and ara-C is highly efficient in PCNSL. A substantial fraction of patients < 60 years can obviously be cured with this regimen.

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Importance of Achieving a Complete Response in Multiple Myeloma, and the Impact of Novel Agents

Journal of Clinical Oncology ◽

10.1200/jco.2009.25.4250 ◽

2010 ◽

Vol 28 (15) ◽

pp. 2612-2624 ◽

Cited By ~ 153

Author(s):

Asher A. Chanan-Khan ◽

Sergio Giralt

Keyword(s):

Multiple Myeloma ◽

Overall Survival ◽

Prognostic Significance ◽

Complete Response ◽

Maximal Response ◽

Prognostic Impact ◽

Long Term Outcomes ◽

First Line ◽

The Impact

The goal of treatment for multiple myeloma (MM) is to improve patients' long-term outcomes. One important factor that has been associated with prolonged progression-free and overall survival is the quality of response to treatment, particularly achievement of a complete response (CR). There is extensive evidence from clinical studies in the transplant setting in first-line MM demonstrating that CR or maximal response post-transplant is significantly associated with prolonged progression-free and overall survival, with some studies demonstrating a similar association with postinduction response. Supportive evidence is also available from studies in the nontransplant and relapsed settings. With the introduction of bortezomib, thalidomide, and lenalidomide, higher rates of CR are being achieved in both first-line and relapsed MM compared with previous chemotherapeutic approaches, thereby potentially improving long-term outcomes. While standard CR by established response criteria has been shown to have differential prognostic impact compared with lesser responses, increasingly sensitive analytic techniques are now being explored to define more stringent degrees of CR or elimination of minimal residual disease (MRD), including multiparameter flow cytometry and polymerase chain reaction. Demonstrating eradication of MRD by these techniques has already been shown to predict for improved outcomes. Here, we review the prognostic significance of achieving CR in MM and highlight the importance of CR as an increasingly realizable goal at all stages of treatment. We discuss clinical management issues and provide recommendations relevant to practicing oncologists, such as the routine use of sensitive techniques for assessment of disease status to inform evidence-based decisions on optimal patient management.

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Vinblastine, Mitoxantrone and Prednisone (MVP) Followed by Involved Field Radiotherapy (IF-XRT) for Early Clinical Stage Hodgkins’s Lymphoma: Long Term Follow-Up.

Blood ◽

10.1182/blood.v106.11.2677.2677 ◽

2005 ◽

Vol 106 (11) ◽

pp. 2677-2677

Author(s):

Danielle Shafer ◽

Hossein Borghaei ◽

Michael Millenson ◽

Nicos Nicolaou ◽

Tahseen I. Al-Saleem ◽

...

Keyword(s):

Overall Survival ◽

Early Stage ◽

Survival Rates ◽

Complete Response ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Combined Modality Treatment ◽

Grade 3

Abstract Background: The treatment of early stage Hodgkin’s lymphoma (HL) continues to evolve in attempt to improve the safety profile of the regimens and decrease their long-term toxicities. Treatment related mortality exceeds that from HL after 12 to 15 years. In light of the potential long-term complications associated with irradiation and chemotherapy, particularly pulmonary and cardiac toxicity, alternative approaches minimizing exposure to drugs with long-term organ toxicity have been examined. Objectives: We evaluated a novel regimen of MVP and IF-XRT for non-bulky early-stage HL. The primary outcomes were response rate and freedom from disease progression. Secondary outcomes were toxicity, specifically pulmonary and cardiac dysfunction. Methods: Patients were enrolled in this multi-site phase 2 study between 1995 and 1999. Eligible patients were 18 years of age or older, had ECOG performance status 0–2 and pathologically confirmed, clinically staged non-bulky Stage I or II HL. Patients received a minimum of four cycles of mitoxantrone 8mg/m2 and vinblastine 6 mg/m2 intravenously on days 1 and 15 of each 28-day cycle. Prednisone 100mg was given orally days 1 to 5 and 15 to 19. Chemotherapy was continued for two additional cycles after complete response, up to eight cycles. Patients then received IF-XRT (30.6 Gy-39.6 Gy) four weeks after completion of chemotherapy. G-CSF was not used as primary prophylaxis. Results: Thirty-four patients were evaluated for response in a final review. A total of 32 patients (94%) achieved a complete remission after combined therapy. Thirty patients (88%) achieved a complete response after chemotherapy alone. At a median follow-up of 49 months (range 16.9–79.7 months), 10 patients had relapsed, and three deaths were documented. None of the deaths occurred during treatment. The median time to progression was 30 months. The overall survival and disease-free survival rates at 5 years were 90% (95% confidence interval [CI], 73–97%) and 78% (95% CI, 58–89%), respectively. The treatment was well tolerated without significant grade 3/4 toxicity. (Grade 3/4 leukopenia 18% of patients; neutropenia 28%) There were no significant changes in DLCO or left ventricular ejection fraction at 12 months observed after chemotherapy. Twenty-one patients received only 4 cycles of chemotherapy; the median dose intensity for the entire group was 85%. Conclusions: As the management of early-stage HL continues to evolve in attempt to reduce long-term toxicity, this trial serves as a reminder of the balance required between efficacy and toxicity in this largely curable population. In this relatively well-tolerated regimen, there was minimal long-term toxicity, but a high number of relapses, most of which were successfully salvaged with resultant excellent 5-year overall survival rates. As the treatment for early-stage HL moves forward, there will undoubtedly be further attempts to modify the ABVD backbone. We await those results as well as long term data from the German Hodgkin Study group investigating reduction of combined modality treatment (HD10) in a similar patient population.

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Long Term Significance of Response in Multiple Myeloma After Stem Cell Transplantation.

Blood ◽

10.1182/blood.v114.22.1811.1811 ◽

2009 ◽

Vol 114 (22) ◽

pp. 1811-1811

Author(s):

Joaquin Martínez-López ◽

Joan Blade ◽

M. Carmen Gomez del Castillo ◽

Maria Victoria Mateos ◽

Adrian Alegre ◽

...

Keyword(s):

Multiple Myeloma ◽

Overall Survival ◽

Stem Cell ◽

Partial Response ◽

Stem Cell Transplantation ◽

Cell Transplantation ◽

Complete Response ◽

Long Term Follow Up

Abstract Abstract 1811 Poster Board I-837 The prognostic significance of achieving complete remission (CR) in Multiple Myeloma (MM) has finally been accepted. However, available studies have been based on series with a median follow-up around 5 years. This time period is insufficient according to the current life expectation of MM. Aim To establish the real effect of prognosis of the different response categories in a cohort of MM patients treated with autologous stem cell transplantation (ASCT) after long term follow up. Patients and methods Follow-up from diagnosis of 344 MM patients transplanted between 1989 and 1998 has been updated. These patients were previously included in a study aimed at establishing the post-ASCT response significance in MM and to validate the EBMT classification (Br J Haemat 2000;109:438-46). It was possible to update the follow up of 322 patients as at April 2009. At this date 99 patients were alive with a median follow-up form diagnosis of 12.5 years. Response categories and evaluated cases were: i) Complete Response (IF-) (CR), n= 84 ii) near Complete Response (EF-/IF+) (nCR), n= 66 iii) Very good partial response (VGPR) (<90% reduction of M component), n= 66 iv) Partial response PR (reduction of M component between 90-50%), n= 113 v) Stable Disease (SD), n= 12, y vi) Progression (PD), n=14 Survival analyses were performed by Kaplan-Meier curves (log-rank test). Cox logistic regression was employed to establish variables associated with a higher survival. Results Significant differences in overall survival (OS) and event free survival (EFS) were found between CR and nCR groups (p 0.01 and 0.0022, respectively); or between CR and VGPR (p 0.0001 and 0.0035); no differences were detected between nRC and VGPR groups (p 0.21 and 0.99) and between these groups and PR group (p 0.1 y p 0.8). OS and EFS of patients with ED o PD were lower than the rest of the groups. Overall survival at 12 years was 43% in CR patients, 21% in nCR, 20% in VGPR, 30% in PR, 8% in SD and 0% in PD groups. Median survival (OS, EFS respectively) of each group was 91 months and 36 m, 26 m and 21 m, 20 m and 15 m, 31 m and 12 m, 8 m and 5 m, and 6 and 1 month. Land-mark study (10 years) found a plateau phase in OS and EFS after 11 years. Twenty two percent of patients are still alive with stable status between 11 and 15.54 years and only two cases had relapsed in the non CR group. In a regression study for OS, response was only one variable with statistical significance (CR P <0.0000, OR 0.044, IC-95%: 0.020-0.30). Conclusions In MM achieving CR after ASCT is the most important prognostic factor even after long-term follow-up. Relapse rate is very low in patients with >11 years of follow-up, this could mean a cure for patients in CR. Disclosures No relevant conflicts of interest to declare.

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Early Clearance of Peripheral Blood Blasts but Not White Blood Cells Is a Powerful Prognostic marker for complete Response and Overall Survival in Patients with Acute Myeloid Leukemia (AML) receiving Induction Chemotherapy

Blood ◽

10.1182/blood.v118.21.1553.1553 ◽

2011 ◽

Vol 118 (21) ◽

pp. 1553-1553

Author(s):

Alfonso Quintas-Cardama ◽

Hagop Kantarjian ◽

Guillermo Garcia-Manero ◽

Mark Brandt ◽

Sherry Pierce ◽

...

Keyword(s):

Overall Survival ◽

Induction Chemotherapy ◽

Peripheral Blood ◽

Conflicts Of Interest ◽

Lymphoblastic Leukemia ◽

White Blood Cells ◽

Complete Response ◽

Long Term Outcomes ◽

Group 1

Abstract Abstract 1553 Background: Most pts with AML will achieve complete remission (CR) following therapy with cytarabine and an anthracycline. Early clearance of blasts in peripheral blood (PB) has been shown to be an important prognostic factor in acute lymphoblastic leukemia. We explored the dynamics of PB blasts in pts with AML undergoing induction chemotherapy with AI (ara-C 1.5g/m2x3d and idarubicin 12mg/m2x3d) at our institution and their impact in long-term outcomes. Patients & Methods: We reviewed the dynamics of PB blasts (i.e. PB blasts=0%) or WBC (i.e. WBC≤0.1×109/dL) clearance in pts with AML receiving AI (n=486). Patients with acute promyelocytic leukemia were excluded. Pt characteristics were as follows: median age 55 yrs (range, 19–73), pts <60 yrs 44 (30%), diploid cytogenetics (n=54, 36%), poor cytogenetics (n=57, 38%), median WBC 4.9 (range, 0.3–97.4), platelets 39 (range, 2–581), hemoglobin 8.4g/dL (range, 3.3–13.2), PB blasts (15% (range, 1–96), BM blasts 45% (1–96). Results: The overall response rate (ORR=CR+CRp) was 65% (58%+7%). Forty-four (30%) pts were resistant to induction therapy. To evaluate the dynamics of PB WBC and PB blast clearance, we divided all pts in 5 groups depending on the day they cleared their WBC or blasts from PB: group 1 (0–1 days), 2 (2–3 days), 3 (4–5 days), 4 (6–8 days), and 5 (beyond day 8). A total of 21, 34, 25, 4, and 3 pts were included in groups 1 through 5. No differences in CR rates were observed across all 5 groups according to the time of clearance of PB WBC (p=0.653). Likewise, similar median overall survival (OS) rates were observed in all 5 groups regardless of the timing of PB WBC clearance (0.2). However, the timing of PB blast clearance was associated with a distinct probability of achieving CR, being 73%, 74%, 65%, 24%, AND 60% for groups 1 through 5 (p=0.003). This translated into distinctly different median OS for the 5 groups (p=0.03) (Figure 1A). When groups 1, 2, and 3 were merged and compared with the merge of groups 4 and 5, the ORR for the resulting two new groups was 71% and 32% (p<0.001) and the corresponding median OS was 40 weeks and 75 weeks (p=0.038) (Figure 1B), suggesting that early PB clearance predicts long-term outcomes. Conclusion: We have shown in a large cohort of uniformly treated pts with AML that early clearance of PB blasts (but not WBC) is an important risk factor for achievement of CR and for OS. Clearance of PB blasts should be considered in prognostication schemas for pts with AML. Disclosures: No relevant conflicts of interest to declare.

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Effect of adjuvant chemotherapy following pathologic complete response on long-term survival in rectal cancer: A propensity score matched analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.717 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 717-717 ◽

Cited By ~ 1

Author(s):

Ali Mokdad ◽

Sergio Huerta ◽

Rebecca M Minter ◽

John C. Mansour ◽

Michael A. Choti ◽

...

Keyword(s):

Rectal Cancer ◽

Overall Survival ◽

Adjuvant Chemotherapy ◽

Clinical Stage ◽

Locally Advanced ◽

Pathologic Complete Response ◽

Rectal Adenocarcinoma ◽

Complete Response ◽

Term Survival

717 Background: The role of adjuvant chemotherapy following resection in patients with rectal cancer that achieve pathologic complete response (pCR) after neoadjuvant therapy is unclear. Current data have been limited by small sample size series. This study examined the impact of adjuvant chemotherapy following pCR on overall survival in a national cohort of patients. Methods: Patients with rectal adenocarcinoma were identified in the National Cancer Data Base between 2006 and 2012. Those with locally advanced tumor (clinical stage II or III) that achieved pCR (defined as ypT0N0 in surgical specimens) after neoadjuvant chemoradiotherapy (nCRT) were included in the study. We matched by propensity score patients that received adjuvant chemotherapy (ACT) and patients that did not receive postoperative treatment (no-ACT) controlling for demographic as well as perioperative patient and tumor characteristics. Overall survival was compared using a Cox proportional hazards model. Results: We identified 2,543 patients (ACT: 732, no-ACT: 1,811 patients) with resected locally advanced rectal adenocarcinoma that achieved pCR after nCRT. Among patients that received ACT, 711 were matched with 711 patients in the no-ACT group. Adjuvant chemotherapy was associated with improved overall survival compared to no-ACT (hazard ratio[HR] = 0.46, 95% confidence interval [CI] = 0.29 – 0.75). Overall survivals at 1, 3, and 5 years in the ACT and no-ACT groups were 100% vs 98% (P=0.1), 98% vs 94% (P<0.01), and 94% vs 89% (P<0.01), respectively. In subgroup analyses, adjuvant chemotherapy improved overall survival in patients with clinical stage II (HR = 0.43, 95% CI = 0.22 – 0.85) as well as stage III tumor (OR = 0.50, 95% CI = 0.26 – 0.98). Among patients that received adjuvant chemotherapy, there was no difference in overall survival between single agent and multiagent regimens (HR = 1.37, 95% CI = 0.57 – 3.29). Conclusions: Adjuvant chemotherapy may providea small long-term survival benefit in patients with resected locally advanced rectal cancer and pCR after nCRT.

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Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results

BMC Cancer ◽

10.1186/s12885-020-07661-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Ramón Salazar ◽

◽

Jaume Capdevila ◽

Jose Luis Manzano ◽

Carles Pericay ◽

...

Keyword(s):

Overall Survival ◽

Locally Advanced ◽

Disease Free Survival ◽

Complete Response ◽

Relapse Free Survival ◽

Free Survival ◽

Link Type ◽

Distant Relapse

Abstract Background Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The “Tratamiento de Tumores Digestivos” group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response). We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years. Methods Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks). Results In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%). Conclusions the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term. Trial registration EudraCT number: 2009–010192-24. Clinicaltrials.gov number: NCT01043484.

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Preoperative Chemotherapy and Radiotherapy in the Management of Epidermoid Carcinoma of the Anal Canal

Tumori Journal ◽

10.1177/030089168707300211 ◽

1987 ◽

Vol 73 (2) ◽

pp. 151-155 ◽

Cited By ~ 2

Author(s):

Giovanni Battista Secco ◽

Mario Roberto Sertoli ◽

Daniele Scarpati ◽

Gianni Marino ◽

Roberto Fardelli ◽

...

Keyword(s):

Overall Survival ◽

Local Recurrence ◽

Partial Response ◽

Anal Canal ◽

Complete Response ◽

Epidermoid Carcinoma ◽

Preoperative Treatment ◽

Term Survival ◽

Initial Surgery

Sixteen patients affected by epidermoid carcinoma of the anal canal were treated preoperatively by means of an i.v. infusion of mitomycin C (15 mg/m2) on day 1 and 5-fluorouracil (750 mg/m2) days 1 to 5, followed by radiotherapy (3000 R in 3 weeks). Four to 6 weeks after the end of radiotherapy the response to the preoperative treatment was evaluated by means of biopsy. A reduction of the neoplastic mass was observed in 13 of the 16 patients. An evident correlation exists between the stage of the tumor and 1) the response to preoperative treatment, 2) local recurrence, and 3) long-term survival. In fact: 3/4 T1 patients reached a complete response (CR), and 1/4 T1, 5/5 T2 and 4/7 T3 patients achieved a partial response (PR); only 3/7 T3 patients never responded to preoperative treatment. After the initial surgery, only T2 (3/5) and T3 (4/7) patients underwent a second operation for a recurrence. Overall survival at 42 months was 62.5 % (T1, 100 %; T2, 80 %; T3, 28.5 2%).

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