Differences In Prognostic Factors Research Articles

Indirect Treatment Comparison of Talimogene Laherparepvec Compared with Ipilimumab and Vemurafenib for the Treatment of Patients with Metastatic Melanoma.

IntroductionFew randomized controlled trials have compared new treatments for metastatic melanoma. We sought to examine the relative treatment effect of talimogene laherparepvec compared with ipilimumab and vemurafenib.MethodsA systematic literature review of treatments for metastatic melanoma was undertaken but a valid network of evidence could not be established because of a lack of comparative data or studies with sufficient common comparators. A conventional adjusted indirect treatment comparison via network meta-analysis was, therefore, not feasible. Instead, a meta-analysis of absolute efficacy was undertaken, adjusting overall survival (OS) data for differences in prognostic factors between studies using a published algorithm.ResultsFour trials were included in the final indirect treatment comparison: two of ipilimumab, one of vemurafenib, and one of talimogene laherparepvec. Median OS for ipilimumab and vemurafenib increased significantly when adjustment was applied, demonstrating that variation in disease and patient characteristics was biasing OS estimates; adjusting for this made the survival data more comparable. For both ipilimumab and vemurafenib, the adjustments improved Kaplan–Meier OS curves; the observed talimogene laherparepvec OS curve remained above the adjusted OS curves for ipilimumab and vemurafenib, showing that long-term survival could differ from the observed medians.ConclusionEven with limited data, talimogene laherparepvec, ipilimumab, and vemurafenib could be compared following adjustments, thereby providing a more reliable understanding of the relative effect of treatment on survival in a more comparable patient population. The results of this analysis suggest that OS with talimogene laherparepvec is at least as good as with ipilimumab and vemurafenib and improvement was more pronounced in patients with no bone, brain, lung or other visceral metastases.FundingAmgen Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0313-x) contains supplementary material, which is available to authorized users.

Predicted survival in patients with brain metastases from colorectal cancer: Is a current nomogram helpful?

ObjectiveTo examine the clinical applicability of a new nomogram by comparing survival of patients with brain metastases from colorectal cancer treated with surgery and/or radiotherapy in the authors’ institutions with nomogram-predicted median survival. MethodsRetrospective analysis of 64 patients treated with comparable approaches and during the same time period as the patients in the nomogram study. Points were assigned for age, performance status, number and site of brain metastases, as required for nomogram use. ResultsIn 46 patients (72%), the observed survival was shorter than the predicted median. The median deviation was −1.4 months. The nomogram underestimated the survival of patients treated with radiosurgery/surgery by a median of 4.2 months, whereas it overestimated the survival of patients treated with whole-brain radiotherapy (WBRT) by a median of 2.1 months (p=0.0001). Nevertheless, all 5 patients with predicted median survival ≤3 months died within 3 months. Among 8 patients with predicted median survival >12 months, 6 (75%) survived for >12 months. Not all prognostic factors in the nomogram correlated with survival. In the multivariate Cox model, only performance status and number of brain metastases were significant, both with p=0.0001. ConclusionDespite differences in prognostic factors and survival of many individual patients, especially those with intermediate prognosis, the nomogram performed promising in poor- and good-prognosis patients. Evaluation of separate prediction tools for patients treated with WBRT and more aggressive local approaches appears warranted in order to minimize the influence of better local control of the brain metastases.

A Modern Radiotherapy Series of Survival in Hispanic Patients with Glioblastoma

Studies have shown racial differences in cancer outcomes. We investigate whether survival differences existed in Hispanic patients with glioblastoma (GBM) compared with other ethnicities from our modern radiotherapy series, because no study to date has focused on outcomes in this group after radiation therapy. We retrospectively evaluated 428 patients diagnosed with GBM from 1996 to 2014 at our institution, divided into 4 groups based on self-report: white, black, Hispanic, and Asian/Indian. The primary outcome was overall survival. We analyzed differences in prognostic factors among the whole cohort compared with the Hispanic cohort alone. Baseline characteristics of the 4 racial groups were comparable. With a median follow-up of 387 days, no survival differences were seen by Kaplan-Meier analysis. Median overall survival for Hispanic patients was 355 days versus 450 days for the entire cohort. Factors significant for patient outcomes in the entire cohort differed slightly from those specific to Hispanic patients. Low Karnofsky Performance Status was significant on multivariate analysis in the whole population, but not in Hispanic patients. Extent of resection, recursive partitioning analysis class, and radiation therapy total dose were significant on multivariate analysis in both the whole population and Hispanic patients. We found that Hispanic patients with GBM had no difference in survival compared with other ethnicities in our cohort. Differences exist in factors associated with outcomes on single and multivariate analysis for Hispanic patients with GBM compared with the entire cohort. Additional studies focusing on Hispanic patients will aid in more personalized treatment approaches in this group.

Clinical features of patients with nodal marginal zone lymphoma compared to follicular lymphoma: similar presentation, but differences in prognostic factors and rate of transformation

Nodal marginal zone lymphoma (NMZL) is a rare type of B-cell non-Hodgkin lymphoma. This study assessed the clinical features of 56 patients with NMZL in comparison to 46 patients with follicular lymphoma (FL). Patients with NMZL and FL had a largely similar clinical presentation, but patients with FL had a higher disease stage at presentation, more frequent abdominal lymphadenopathy and bone marrow involvement, and showed more common transformation into diffuse large B-cell lymphoma (DLBCL) during the course of disease. Overall survival and event-free survival were similar for patients with NMZL and FL, but factors associated with worse prognosis differed between the two groups. Transformation into DLBCL was associated with a significantly poorer outcome in both groups, but the phenotypes were different: DLBCL arising in FL was mainly of germinal center B-cell phenotype, whereas DLBCL arising in NMZL was mainly of non-germinal center B-cell phenotype.

Long-term results of chemoradiotherapy for stage II-III thoracic esophageal cancer in a single institution after 2000 -with a focus on comparison of three protocols-

BackgroundTo evaluate the long-term results of chemoradiotherapy (CRT) for stage II-III thoracic esophageal cancer mainly by comparing results of three protocols retrospectively.MethodsBetween 2000 and 2012, 298 patients with stage II-III thoracic esophageal cancer underwent CRT. Patients in Group A received two cycles of cisplatin (CDDP) at 70 mg/m2 (day 1 and 29) and 5-fluorouracil (5-FU) at 700 mg/m2/24 h (day 1–4 and 29–32) with radiotherapy (RT) of 60 Gy without a break. Patients in Group B received two cycles of CDDP at 40 mg/m2 (day 1, 8, 36 and 43) and 5-FU at 400 mg/m2/24 h (day 1–5, 8–12, 36–40 and 43–47) with RT of 60 Gy with a 2-week break. Patients in Group C received two cycles of nedaplatin at 70 mg/m2 (day 1 and 29) and 5-FU at 500 mg/m2/24 h (day 1–4 and 29–32) with RT of 60–70 Gy without a break. Differences in prognostic factors between the groups were analyzed by univariate and multivariate analyses.ResultsThe 5-year overall survival rates for patients in Group A, Group B and Group C were 52.4, 45.2 and 37.2 %, respectively. The 5-year overall survival rates for patients in Stage II, Stage III (non-T4) and Stage III (T4) were 64.0, 40.1 and 22.5 %, respectively. The 5-year overall survival rates for patients who received 1 cycle and 2 cycles of concomitant chemotherapy were 27.9 and 46.0 %, respectively. In univariate analysis, stage, performance status and number of concomitant chemotherapy cycles were significant prognostic factors (p < 0.001, p = 0.008 and p < 0.001, respectively). In multivariate analysis, stage, protocol and number of concomitant chemotherapy cycles were significant factors (p < 0.001, p = 0.043 and p < 0.001, respectively).ConclusionsThe protocol used in Group A may be an effective protocol of CRT for esophageal cancer. It may be important to complete the scheduled concomitant chemotherapy with the appropriate intensity of CRT.

Male Breast Cancer Prognostic Factors Versus Female Counterparts with Propensity Scores and Matched-Pair Analysis.

Objective: To assess the effect of prognostic factors and their impact on survival in male and female breast cancer.Methods: Medical records for men and women diagnosed with breast cancer referred to the cancer center for treatment were reviewed. Patients with distant metastatic diseases were excluded. Data on prognostic factors including age, nodal status, resection margin, use of hormonal therapy, chemotherapy with and without hormone and radiation therapy (RT), survival, and recurrence were analyzed. Survival estimates were obtained using Kaplan-Meier methodology. The Cox regression interaction was used to compare male and female differences in prognostic factors. Male breast cancer (MBC) and female breast cancer (FBC) were matched according to propensity scores and survival compared using Cox regression.Results: From 1963-2006, there were 75 MBC and 1,313 FBC totaling 1,388 breast cancers. The median age of the cohort was 53 (range: 23-90) years. Median follow-up was 90 (range: 0.4-339) months. Prognostic factors of patients were balanced among the groups after adjusting for propensity scores. A Cox model adjusting for propensity scores showed that overall survival (OS) (HR= 2.52 (1.65, 3.86), P<0.001) and distant disease recurrence-free survival (DDRFS) (HR= 2.39 (0.75, 3.04), P=0.003) were significantly different for MBC and FBC. Analyses that stratified by propensity score quintiles had similar findings: OS HR=2.41 (1.67, 3.47), P<0.001); DDRFS HR=2.89 (1.81, 4.60), P<0.001). When MBC and FBC were matched (1:3) by propensity scores, differences between MBC and FBC were again observed in OS (HR=1.94, 95%CI:1.18-3.19, P=0.009) and DDRFS (HR=2.79, 95%CI:1.36-5.75, P=0.005) with MBC at a higher risk of death and disease recurrence compared to FBC .Conclusion: This large series showed that MBC and FBC survivals are not similar, with MBC having a worse outcome. The finding of this study needs confirmation from a complete prospective database.

Differences in Prognostic Factors between Early and Late Recurrence Breast Cancers.

Breast cancer (BC) is the most frequent malignancy among females and is a leading cause of death of middle-aged women. Herein, we evaluated baseline characteristics for BC patients and also compared these variables across ealry and late recurrence groups. Between 1995 to 2014, among female breast cancer patients referred to our oncology clinic, eighty-six were entered into our study. All had distant metastasis. Early recurrence was defined as initial recurrence within 5 years following curative surgery irrespective of site. Likewise, late recurrence was defined as initial recurrence after 5 years. No recurrence was defined for survivors to a complete minimum of 10 years follow-up. Significant prognostic factors associated with early or late recurrence were selected according to the Akaike Information Criterion. The median follow-up was 9 years (range, 1-18 years). During follow-up period, 51 recurrences occurred (distant metastasis), 31 early and 20 late. According to the site of recurrence, there were 51 distant. In this follow-up period, 19 patients died. Compared with the early recurrence group, the no recurrence group had lower lymph node involvement and more p53 positive lesions but the late recurrence group had lower tumor size. In comparison to no recurrence, p53 (odds ratio [OR] 6.94, 95% CI 1.49-32.16) was a significant prognostic factor for early recurrence within 5 years. Tumor size, p53 and LN metastasis are the most important risk factors for distance recurrence especially in early recurrence and also between of them, p53 is significant prognostic factor for early recurrence.

Prognostic Impact of Histologic Type in Curatively Resected Stage IV Colorectal Cancer: A Japanese Multicenter Retrospective Study.

This study aimed to clarify differences in prognostic factors, metastatic features, and recurrence rates between histologic types in patients with stage 4 colorectal cancer (CRC) who had undergone curative resection. The data from 1131 patients with stage 4 colorectal cancer from the databases of referral institutions were analyzed. The patients were divided into two groups according to histologic types as follows: patients with poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet-ring cell carcinoma (Por/Muc/Sig) and patients with well-differentiated or moderately differentiated adenocarcinoma (Wel/Mod). Differences in clinicopathologic features, relapse-free survival (RFS) rates, and cancer-specific survival (CSS) rates between the groups were evaluated. Although RFS did not differ between the Por/Muc/Sig and Wel/Mod groups, CSS was significantly shorter in the Por/Muc/Sig group's than in the Wel/Mod group, and survival after recurrence was significantly worse in the Por/Muc/Sig group than in theWel/Mod group. The incidence of peritoneal or local recurrence was significantly higher for the Por/Muc/Sig patients, whereas the resection recurrence rate was 16.4 %. Multivariate analysis suggested that histologic type was an independent prognostic factor for survival after recurrence. The patients with Por/Muc/Sig CRC synchronous metastasis had significantly shorter survival times than the patients with other CRC histologies, even if the metastases were curatively resected.

Gender differences in prognostic factors for oral cancer

The aim of this study was to assess gender differences in prognostic factors among patients treated surgically for oral squamous cell carcinoma (OSCC). The medical records of 477 eligible patients (345 males, 132 females) obtained from the Brazilian Cancer Institute were reviewed. Survival was calculated by Kaplan–Meier method. Cox regression models were used to obtain adjusted hazard ratios (aHR) for males and females. Multivariate analysis showed that past tobacco use (aHR 0.2, 95% confidence interval (CI) 0.1–0.7) and regional metastasis (aHR 2.3, 95% CI 1.5–3.5) in males, and regional metastasis (aHR 2.2, 95% CI 1.2–4.3), distant metastasis (aHR 6.7, 95% CI 1.3–32.7), and hard palate tumours (aHR 11.8, 95% CI 3.3–47.7) in females, were associated with a higher risk of death. There were no differences in survival between males and females. Regional metastasis was found to be a negative prognostic factor in OSCC for both genders. Past tobacco use was an independent prognostic factor for worse survival among males, while distant metastasis and hard palate tumours were independent prognostic factors for worse survival among females. Further studies are necessary to corroborate the relationships found in this study.

Prognostic Impact of Preoperative Tumor Marker Levels and Lymphovascular Invasion in Pathological Stage I Adenocarcinoma and Squamous Cell Carcinoma of the Lung

Some unfavorable prognostic factors for stage I non-small-cell lung cancers have been reported; however, they are not reflected in the current Tumor-Node-Metastasis classification. We retrospectively reviewed 629 patients who underwent complete resection of pathological stage I adenocarcinomas (ADs) or squamous cell carcinomas (SQs) at two institutes between 1996 and 2011. The correlation between clinicopathological characteristics and survival rates was analyzed to identify prognostic factors. Multivariate analysis indicated that among ADs, high serum carcinoembryonic antigen levels (p = 0.04 for overall survival [OS]; p < 0.01 for recurrence-free survival [RFS]; p = 0.02 for disease-specific survival [DSS]), lymphatic permeation (p < 0.01 for RFS and DSS), and vascular invasion (p < 0.01 for OS and RFS; p = 0.03 for DSS) were independent prognostic factors. Among SQs, high squamous cell carcinoma antigen (SCC) (p < 0.05 for OS), and vascular invasion (p < 0.05 for RFS and DSS) were independently prognostic. We suggest that among completely resected tumors less than or equal to 5 cm without lymph node metastasis, the current stages IA and IB AD with high serum carcinoembryonic antigen levels, lymphatic permeation, or vascular invasion should be upgraded to stage IB and IIA, respectively. The current stage IA SQ with high SCC antigen levels or vascular invasion should be upgraded to stage IB. These reclassifications accurately reflect survival status (p < 0.04 in all comparisons). Some important differences in prognostic factors were observed between AD and SQ. High preoperative serum tumor marker levels and lymphovascular invasion should be included as additional criteria in the forthcoming Tumor-Node-Metastasis staging.

Differences in Prognostic Factors and Failure Patterns Between Invasive Micropapillary Carcinoma and Carcinoma With Micropapillary Component Versus Invasive Ductal Carcinoma of the Breast: Retrospective Multicenter Case–Control Study (KROG 13-06)

PurposeWe designed the present study to investigate differences in prognostic factors and failure patterns between patients with invasive micropapillary carcinoma or carcinoma with micropapillary component (IMPC) and randomly matched patients with invasive ductal carcinoma (IDC) of the breast at multiple institutions of the Korean Radiation Oncology Group (KROG). Materials and MethodsThis retrospective multicenter study was performed using subjects treated from January 1999 to November 2011. Female patients who had undergone curative resection for breast cancer without neoadjuvant chemotherapy were considered for this study. Exact matches were made for age (± 3 years), pathologic tumor and node stage, treatment method (surgery with or without radiotherapy), and period when surgery was performed (within 1 year) at the same institution. ResultsA total of 534 patients were analyzed. The median follow-up period was 59 months in both groups. In the comparison of clinicopathologic characteristics, rates of lymphovascular invasion (LVI) and nuclear grade III were both significantly higher in IMPC than in IDC (P < .001, P = .01, respectively). During the follow-up period, recurrences developed in 40 patients with IMPC (15.0%) and 21 with IDC (7.9%). Locoregional recurrence (LRR) developed in 22 patients with IMPC (8.2%) and 10 with IDC (3.7%). The rate of distant metastasis did not differ between the 2 groups (P = .52). LRR-free survival (P = .03) and recurrence-free survival (P = .007) were significantly different between the 2 groups, but overall survival was not (P = .67). ConclusionIMPC is associated with a higher rate of LVI, high nuclear grade, and a propensity for LRR compared to IDC. Modification of the locoregional treatment modality might be needed in this pathologic subtype of breast cancer.

Male Breast Cancer Prognostic Factors: Similarity to Female Counterparts With Propensity Scores and Matched-Pair Analysis

Objective: To assess the effect of prognostic factors and their impact on survival in male and female breast cancer. Methods: Medical records for men and women diagnosed with breast cancer referred to the cancer center for treatment were reviewed. Patients with distant metastatic diseases were excluded. Data on prognostic factors including age, nodal status, resection margin, use of hormonal therapy, chemotherapy with and without hormone and radiation therapy (RT), survival, and recurrence were analyzed. Survival estimates were obtained using Kaplan-Meier methodology. The Cox regression interaction was used to compare male and female differences in prognostic factors. Male breast cancer (MBC) and female breast cancer (FBC) were matched according to propensity scores and survival compared using Cox regression. Results: From 1963-2006, there were 75 MBC and 1,313 FBC totaling 1,388 breast cancers. The median age of the cohort was 53 (range: 23-90) years. Median follow-up was 90 (range: 0.4339) months. Prognostic factors of patients were balanced among the groups after adjusting for propensity scores. A Cox model adjusting for propensity scores showed that overall survival (OS) (HR= 2.52 (1.65, 3.86), P<0.001) and distant disease recurrence-free survival (DDRFS) (HR= 2.39 (0.75, 3.04), P=0.003) were significantly different for MBC and FBC. Analyses that stratified by propensity score quintiles had similar findings: OS HR=2.41 (1.67, 3.47), P<0.001); DDRFS HR=2.89 (1.81, 4.60), P<0.001). When MBC and FBC were matched (1:3) by propensity scores, differences between MBC and FBC were again observed in OS (HR=1.94, 95%CI:1.18-3.19, P=0.009) and DDRFS (HR=2.79, 95%CI:1.36-5.75, P=0.005) with MBC at a higher risk of death and disease recurrence compared to FBC . Conclusion: This large series showed that MBC and FBC survivals are not similar, with MBC having a worse outcome. The finding of this study needs confirmation from a complete prospective database. 1 2 3 4 5 6 7 8 Open Access Original Article DOI: 10.7759/cureus.355 How to cite this article Yu E, Stitt L, Vujovic O, et al. (October 16, 2015) Male Breast Cancer Prognostic Factors Versus Female Counterparts with Propensity Scores and Matched-Pair Analysis . Cureus 7(10): e355. DOI 10.7759/cureus.355 Categories: Oncology, Radiation Oncology

A Propensity Score Adjusted Analysis of Patients Receiving Up-Front SRS Versus WBRT: Does the Use of Upfront WBRT Really Affect Neurologic Death?

analyses the independent prognostic factors according to the histology of the primary tumor are as follows: Breast e KPS < 70% (HR Z 1.84); no PTC (HR Z 1.47), no chemotherapy [CT] (HR Z 1.49); no RS (HR Z 2.34). Lung e KPS < 70% (HR Z 1.80); no PTC (HR Z 2.10); no FT (HR Z 2.90 for RS and 1.72 for SG, respectively). Melanoma e no FT (HR Z 4.38 for RS and 2.28 for SG, respectively). GI e no SG (HR Z 4.19). All tumors e KPS < 70% (HR Z 1.70); no PTC (HR Z 1.42); no CT (HR Z 1.42), no FT (HR Z 2.48 for RS and 2.11 for SG, respectively); ECM (HR Z 1.48). *All p value < 0.05. Conclusions: Comparing our data to DS-GPA we observe differences in prognostic factors for breast cancer (PTC, CT and FT), lung cancer (PTC and FT), melanoma (FT) and GI (FT). ECM was just significant when it was analyzed all tumor types together and the number of BM was not an independent factor in this study. The FT was correlated with improved survival in all tumor histology. The inclusion of new prognostic factors could further refine DS-GPA. Author Disclosure: M.G. Silva: None. D.F.G. Neves: None. F.L.C. Faustino: None. D.F. Ferreira: None. A.C.A. Pellizon: None. R.C. Fogaroli: None. D.G. Castro: None. M.J. Chen: None.

Frameless Hypofractionated Robotic Radiosurgery for Cerebral Arteriovenous Malformations: Early Clinical Report on Obliteration Rate, Bleeding Risk, and Toxicity

analyses the independent prognostic factors according to the histology of the primary tumor are as follows: Breast e KPS < 70% (HR Z 1.84); no PTC (HR Z 1.47), no chemotherapy [CT] (HR Z 1.49); no RS (HR Z 2.34). Lung e KPS < 70% (HR Z 1.80); no PTC (HR Z 2.10); no FT (HR Z 2.90 for RS and 1.72 for SG, respectively). Melanoma e no FT (HR Z 4.38 for RS and 2.28 for SG, respectively). GI e no SG (HR Z 4.19). All tumors e KPS < 70% (HR Z 1.70); no PTC (HR Z 1.42); no CT (HR Z 1.42), no FT (HR Z 2.48 for RS and 2.11 for SG, respectively); ECM (HR Z 1.48). *All p value < 0.05. Conclusions: Comparing our data to DS-GPA we observe differences in prognostic factors for breast cancer (PTC, CT and FT), lung cancer (PTC and FT), melanoma (FT) and GI (FT). ECM was just significant when it was analyzed all tumor types together and the number of BM was not an independent factor in this study. The FT was correlated with improved survival in all tumor histology. The inclusion of new prognostic factors could further refine DS-GPA. Author Disclosure: M.G. Silva: None. D.F.G. Neves: None. F.L.C. Faustino: None. D.F. Ferreira: None. A.C.A. Pellizon: None. R.C. Fogaroli: None. D.G. Castro: None. M.J. Chen: None.

Transfacial versus endoscopic approach in the treatment of woodworker's nasal adenocarcinomas

The purpose of this study was to present a monocentric retrospective study designed to compare oncologic results and morbidity between transfacial surgery and endoscopic endonasal surgery for nasal adenocarcinomas. Between 1998 and 2003, 31 patients were operated on via transfacial surgery, and between 2004 and 2009, 43 patients were operated on via endoscopic endonasal surgery. Overall and specific survival, local control, and morbidity (length of hospitalization, intensive care unit [ICU] monitoring, need for nasal packing, and complications) were compared. There was no difference in prognostic factors between groups, but the median age was significantly higher for endoscopic endonasal surgery. Three-year overall survival, specific survival, and local control were not different between groups (respectively, 76.7%, 86%, and 81.4% for endoscopic endonasal surgery vs 61.3%, 67.7%, and 71% for transfacial surgery). Morbidity was significantly lower with endoscopic endonasal surgery for all criteria. Endoscopic surgery may replace transfacial surgery in the treatment of woodworker's adenocarcinomas. Older patients can be operated on by decreasing morbidity and mortality with at least similar oncologic results.

Prognostic role of en-bloc resection and late onset of bone metastasis in patients with bone-seeking carcinomas of the kidney, breast, lung, and prostate: SSG study on 672 operated skeletal metastases.

In metastatic disease, decisions regarding potential surgery require reliable data about the patient's survival. In this study, we evaluated different prognostic factors and their impact in four common primary tumors causing bone metastases. Data were acquired from the Scandinavian Sarcoma Group (SSG) metastasis registry. The patients underwent surgery between July 1999 and July 2009. This study included breast, prostate, lung, and kidney cancer cases, with a total of 672 operated non-spinal metastases. Differences in prognostic factors were evaluated using the Kaplan-Meier method with long-rank test. Cox regression multivariate analysis was performed to identify statistically independent prognostic factors. Significant factors affecting survival were the presence of organ metastases, overall heath status, and disease load. In kidney cancer, en bloc resection of solitary metastases was associated with a significant fourfold longer survival compared to intralesional surgery. Preoperative radiotherapy was associated with higher complication and reoperation rates. This data summary is important tool for clinicians to evaluate survival and choose treatment options for patients suffering from metastatic bone disease.

Randomized trials with missing outcome data: how to analyze and what to report.

The gold-standard study design to evaluate the effects of medical treatment is the randomized trial. Assignment to treatment groups is a random process, and baseline differences in prognostic factors are due to chance. Consequently, at baseline, both groups are expected to be statistically

Resection of Pulmonary Metastases from Colon and Rectal Cancer: Factors to Predict Survival Differ Regarding to the Origin of the Primary Tumor

The purpose of the present study was to determine differences in prognostic factors for survival of patients with pulmonary metastases resected in curative intent from colon or rectum cancer. Between 1980 and 2006, prognostic factors after resection of pulmonary metastases in 171 patients with primary rectum or colon tumor were evaluated. Survival of patients after surgical metastasectomy was compared with that of patients receiving standard chemotherapy by matched-pair analysis. Median survival after pulmonary resection was 35.2months (confidence interval 27.3-43.2). One-, 3-, and 5-year survival for patients following R0 resection was 88.8, 52.1, and 32.9% respectively. Complete metastasectomy (R0), UICC stage of the primary tumor, pleural infiltration, and hilar or mediastinal lymph node metastases are independent prognostic factors for survival. Matched-pair analysis confirmed that pulmonary metastasectomy significantly improved survival. Although no difference in survival for patients with pulmonary metastases from lower rectal compared to upper rectal or colon cancer was observed, factors to predict survival are different for patients with lower and middle rectal cancer (R0, mediastinal and/or hilar lymph nodes, gender, UICC stage) compared with patients with upper rectal or colon cancer (R0, number of metastases). Our results indicate that distinct prognostic factors exist for patients with pulmonary metastases from lower rectal compared with upper rectal or colon cancer. This supports the notion that colorectal cancer should not be considered as a single-tumor entity. Metastasectomy, especially after complete resection resulted in a dramatic improvement of survival compared with patients treated with chemotherapy alone.

Comparison of Outcomes between Women with &lt;i&gt;De novo&lt;/i&gt; Stage IV and Relapsed Breast Cancer

Patients with de novo stage IV and relapsed breast cancer are often treated with the same strategy. However, survival differences have recently been reported between the disease types. The aim of this study was to compare outcomes between de novo stage IV disease and relapsed disease and to discuss any differences in prognostic factors between them. The subjects were 79 patients with de novo stage IV disease and 213 patients with relapsed disease treated at the Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, from October 2001 through November 2010. The Kaplan-Meier method was used to estimate overall survival (OS), and the Cox proportional hazards model was used to examine the association between metastatic disease and OS. The median follow-up period was 32 months for de novo stage IV disease and 34 months for relapsed disease. The median OS was 46 months and 43 months, respectively. No significant differences were evident. Identified prognostic factors were performance status and liver metastasis for de novo stage IV disease, and performance status, hormone receptor status, solitary bone metastasis, and disease-free interval for relapsed disease. No differences in outcome were found between de novo stage IV disease and relapsed disease. However, their prognostic factors differed substantially and suggest that different treatment strategies may be warranted for metastatic disease in each type of breast cancer.

Abstract P3-12-05: The BC provincial experience on FEC-D vs. AC-taxane protocol as adjuvant treatment for breast cancer

Abstract Background: Despite no direct prospective comparison, FECD and AC-Taxane (ACT) combinations are usually considered equally effective treatment options for early breast cancer. We evaluated the outcomes of patients (pts) in the BCCA database treated with FECD or ACT adjuvant chemotherapy between Jan/06 and Dec/11. Methods: Female pts with a diagnosis of stage I-III breast cancer were eligible. The primary end-point was RFS (defined as freedom from local, regional or distant recurrence, or breast cancer death without documented recurrence). Secondary end-points were OS, number of cycles, chemotherapy delays, dose reductions, change in chemo protocol, and toxicity profile. Results: 2013 pts were included: 1137 in the ACT and 876 in the FECD arm. Mean age was 52 (24-79). Baseline characteristics for ACT and FECD were, respectively: ductal histology in 95.5% vs 89.1% and lobular histology in 4% vs 10.6%; tumor size of 0.1-2.0 cm in 37 vs 34%, 2.1-5.0 cm in 50 vs 56% and ≥ 5.1 cm in 11 vs 9%; number of involved nodes were 0 in 42 vs 7%, 1-3 in 32 vs 65%, 4-9 in 16 vs 22% and ≥ 10 in 8 vs 6%; grade 1 in 2% vs 10%, grade 2 in 23% vs 40% and grade 3 in 74% vs 50%; ER/PR positive (+) in 21 vs 85%; ER/PR+/HER2+ in 40 vs 2%, ER/PR negative/HER2+ in 19 vs &amp;lt;1%, and triple negative in 18 vs 11%; local therapy consisted of breast conserving surgery (BCS) in 4 vs 1%, BCS + radiation (RT) in 42 vs 41%, mastectomy (Mx) in 16 vs 6%, Mx + RT in 36 vs 51%, and RT only to 1.5 vs &amp;lt; 1%. ACT and FECD arms showed a 5-year RFS of 84.3% vs 88.2%, and a 5-year OS of 88.2% vs 91.1%, respectively. After adjusting for tumor size, nodal involvement, histology, and LVI, pts in the ACT arm had a higher risk of relapse (HR = 2.269; 95% CI 1.528-3.368), and worse overall survival (HR = 1.796; 95% CI 1.128-2.857) than pts on FECD arm. A total of 815 cases have been reviewed to date for toxicity and chemotherapy delivery. In the ACT (415 pts) and FECD (400 pts) arms, respectively, 96.6% and 98.5% pts received the total number of planned anthracycline cycles, while 91.6% and 88.5% received the total number of planned taxane cycles. There was a dose delay in 36% and 40% of pts, a dose reduction in 30% and 41% of pts, and a change in protocol in 3% and 7% of pts in the ACT and FECD arms, respectively. Chemotherapy-related toxicity events leading to delay, dose reduction and change in protocol occurred in 119 (28.7%) and 216 (54%) pts in the ACT and FECD arms (p 0.01). The number of specific events for the ACT and FECD arms were, respectively: 15 (3.6%) vs 68 (17%) cases of febrile neutropenia, 11 (2.7%) vs 22 (5.5%) cases of grade 3 neutropenia, 46 (11.1%) vs 10 (2.5%) cases of neuropathy, 8 (1.9%) vs 33 (8.3%) cases of mucositis, and 5 (1.2%) vs 2 (0.5%) cases of cardiac toxicity. Conclusions: Characteristics between arms were imbalanced due to the retrospective nature of the study. After adjustment for risk factors, relapse free and overall survival outcomes were better for the FECD arm. However, FECD had a worse toxicity profile, with a higher rate of life threatening events. The survival benefit was small, and it is possible that uncontrolled differences in prognostic factors that affected the choice for the ACT regimen may have lead to these findings, rather than inferiority of the ACT protocol itself. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-12-05.