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Introduction Hepatic resection is the only potentially curative treatment for patients with colorectal liver metastases (CLM). Patient selection is key, but there is wide variation in practice. Pre-operative chemotherapy can improve oncological outcomes, however chemotherapy-associated liver injury (CALI) may hinder liver regenerative capacity. Standard pre-operative assessments fail to accurately capture factors such as CALI and future liver remnant (FLR) function. The CLiFF and CoNoR studies utilise two novel assessment techniques, aiming to improve patient outcomes. Method The CLiFF study prospectively assesses two primary outcomes in 35 patients undergoing pre-operative chemotherapy for CLM: 1) change in liver function (via LiMAx test: direct assessment of hepatic functional capacity), and 2) change in liver fat (via advanced MR imaging (in-house spectroscopy and modified Dixon technique, scaled up via Perspectum LiverMultiScan)). The CoNoR study assesses potential added benefit of these novel tools in CLM resectability decision-making via sequential workstreams: a systematic review and international hepatobiliary expert interviews inform the online survey, assessing added benefit via online MDT scenarios. Result Preliminary CLiFF analysis suggests that CALI changes in liver fat and function are unrelated. Liver fat analysis techniques are compared and correlated with digital histological analysis. The CoNoR systematic review identifies key factors influencing CLM resectability decision-making and informs the international expert interviews, scheduled to occur during a February 2020 international hepatobiliary conference. Conclusion These studies are the first to assess where these novel tools might be utilised to maximal patient benefit within the Hepatobiliary MDT, and the first systematic review in CLM resectability decision-making. Take-home message These two linked studies evaluate the use of two novel assessment tools in the treatment of colorectal liver metastases, with the potential to improve patient selection for curative resection and patient outcomes. PATEY PRIZE SESSION

Introduction The CREATE-X study, conducted in Japan and South Korea, established capecitabine as an adjuvant treatment option for patients with triple negative breast cancer (TNBC) who have residual disease (RD) following neoadjuvant anthracycline or taxane-based chemotherapy. However, there are no reports on the tolerability and outcomes of adjuvant capecitabine in the US setting following publication of the CREATE-X data. Methods We retrospectively collected treatment and tolerability data from the medical records of the first 23 TNBC patients who received adjuvant capecitabine for RD post neoadjuvant chemotherapy at our institution. Disease-free survival was assessed using the Kaplan-Meier method. Results The median starting dosage of capecitabine was 1871 mg/m2/day, most commonly divided into two daily doses on days 1-14 of each 21 day cycle. 34.8% of patients completed the treatment as prescribed. Side effects associated with treatment were common with 69.6% of patients experiencing hand-foot syndrome, 39.1% of patients experiencing diarrhea, and 13.0% of patients requiring hospitalization for side effects. Of 23 patients treated with adjuvant capecitabine, 34.8% completed the planned dose, 30.4% completed with dose reduction, and 34.8% discontinued early. At a median follow-up time of 14 months, the median disease-free survival was 22 months, with 30.4% of patients experiencing recurrence. Conclusion Tolerability was poor overall compared to the CREATE-X cohort. Administering adjuvant capecitabine for TNBC patients with residual disease in the United States is challenging given differences in tolerability. More research is needed to understand how poor tolerability will affect the efficacy of this approach in the US population.

The method used to evaluate the response of osteosarcoma to preoperative chemotherapy before specimen resection is still unclear. The purpose of this study was to identify factors that contribute to overall survival (OS) and to discuss their roles in making a decision regarding Enneking surgical margins. Patients (109) with pathologically confirmed Enneking stage IIB osteosarcoma were retrospectively analyzed. Univariate and multivariate survival analyses were performed. Patient characteristics and chemotherapy-induced contrast-enhanced MRI changes were considered as potential factors. Changes in the tumor volume and the relative necrosis ratio measured by MRI were independent risk factors predicting the OS of patients who underwent limb-salvage surgery. For those in whom the tumor volume had decreased (VolRatio

Objective To compare surgical aspects of Wilms' tumor in patients with or without pre-operative chemotherapy. Method The records of all diagnosed cases of Wilms' tumor treated between January 2011 and December 2015 were retrospectively analysed. They were divided in two groups. Group I included patients treated with pre-operative chemotherapy and group II comprised of those who didn't receive chemotherapy before surgery. They were compared with respect to size of tumour at time of surgery, duration of surgery, tumor rupture, blood loss, extent of excision, adherence and damage to surrounding structures and peri-operative complications. Result Both groups had 10 patients each. Mean size of tumor at the time of presentation in group I was 859.9 cc and average volume reduction of tumor was 22% after chemotherapy. In group II the mean size of tumor was 890.4 cc. Average duration of surgery in group I was 3.3 hours and in group II 2.8 hours.Adherence to adjacent organs were seen in 5 cases (50%) in group I whereas in only one case in group II. Rupture of tumour was not reported in group I whereas in group II it occurred in three cases (30%). Conclusion Although primary surgery is feasible, yet the incidence of tumour rupture and intra operative complication tends to be higher in patients undergoing primary surgery.

The timing and role of chemotherapy in the management of Wilms' tumor has long been the matter of debate, with different groups showing equally comparable and encouraging results. Over the last decade, however, both the ideol-ogies seem to be converging and the attempt has been to identify groups benefitting with pre-operative chemotherapy, as well as those, where upfront resection should be attempted. In this article authors intend to discuss pros and cons of both the strategies and their applicability in a resource poor setting in developing countries like India.

Background Recently a procedure termed 'Associating Liver Partition and Portal vein ligation for Staged hepatectomy' (ALPPS) was developed to increase the resectability of marginally resectable or locally unresectable liver tumours. This study focused on the application of ALPPS in patients with advanced colorectal liver metastases (CRLM) and pre-operative chemotherapy, with the aim to investigate whether the latter still allows for sufficient hypertrophy of the future liver remnant (FLR) following the first step of ALPPS. Methods Retrospective analysis was performed on six patients suffering from advanced CRLM. Analyses comprised demographical and basic clinical data, the perioperative courses as well as short- and long-term outcomes. Results All patients presented with bilobular CRLM and pre-operative chemotherapy of at least 6 months. Extended right hemihepatectomy was performed in all cases, four patients additionally received atypical resections in segments II/III. Mean FLR prior to step 1 of ALPPS was 397.9 cm3 (121-753 cm3 ), on average representing 20.9% of the total liver volume (13.2-27.1%). A mean hypertrophy of the FLR of 67.9% (32.5-94.1%) was achieved. Overall, severe morbidity (Dindo Clavien >3a) occurred in two patients. Following completion of ALPPS, mean post-operative disease-free survival was 5.7 months (2.6-8.9 months). Conclusion Despite pre-operative chemotherapy, ALPPS seems to result in adequate liver hypertrophy, preventing post-operative small-for-size syndrome. However, there might be a high risk of tumour recurrence in patients with an aggressive tumour biology.

Background and Objectives Study objectives, included determination of: (i) associations between radiologic and pathologic responses of colorectal cancer liver metastases (CRCLM) to chemotherapy; and (ii) whether CRCLM histopathology is associated with recurrence free survival (RFS) after resection among patients not treated with pre-operative chemotherapy (untreated). Methods Demographics, clinicopathologic characteristics, and outcomes among patients who underwent CRCLM resection from 2007 to 2014 were reviewed. Tumor regression grade (TRG) of 1–2 and 4–5 depict low and high proportions of viable tumor relative to fibrosis, respectively. Results Of 138 patients, 84 (60.9%) were treated with pre-operative chemotherapy. In these patients, there was no difference in proportions with TRG 1–2 among those with verses without radiologic response (26.9% vs. 18.8%, P = 0.393). TRG 1–2 was associated with superior RFS on univariable (median 15 vs. 6 months, P

Currently, surgery remains the only approach to cure gastric cancer. However, improvement of prognosis by surgical resection alone is limited, and peri-operative chemotherapy is necessary (1). In recent years, several large clinical trials have shown the effectiveness of adjuvant post-operative chemotherapy for gastric cancer (2-4). In contrast, the usefulness of adjuvant pre-operative chemotherapy has not been fully demonstrated.

BackgroundNeoadjuvant chemotherapy for colorectal liver metastases (CRLM) reduces the accuracy of liver imaging which may understage patients pre-operatively. Retrospective review of a prospective database to determine whether liver-specific magnetic resonance imaging (MRI) prior to pre-operative chemotherapy affects intra-hepatic recurrence and long-term outcome after hepatectomy.Patients and methodsBetween 2003 and 2009, 242 patients with CRLM underwent a hepatectomy after ≥3 cycles of oxaliplatin or irinotecan-based chemotherapy. All had a liver-specific MRI immediately pre-operatively. The outcome of patients who had a liver-specific MRI prior to chemotherapy (PCI group, n= 92) was compared with those who did not (non-PCI group, n= 150).ResultsA liver-specific MRI pre-chemotherapy changed the staging in 56% of patients. At a median (range) follow-up of 55 (6–94) months, there was a higher incidence of intra-hepatic recurrence at a new site in the non-PCI group (65% vs. 48% in the PCI group, P= 0.041) and an increased rate of recurrence in patients with the same number of lesions pre- and post-chemotherapy [hazard ratio (HR) 2.02, 1:10–3.37, P= 0.024]. The non-PCI group underwent more repeat hepatectomies than the PCI group (24.7% vs. 13%, P= 0.034), achieving similar long-term survival.ConclusionsA liver-specific MRI prior to chemotherapy reduces intra-hepatic recurrence and avoids a repeat hepatectomy.

Gastric cancer is highly prevalent in several countries around the world and remains an incurable disease. Treatment involves surgery, chemotherapy and radiation. Surgical resection remains the definitive treatment for early stage (T1 and T2) gastric cancer, with 5-year survival rates of 70-95%. Localized tumours that extend beyond the submucosa are, however, associated with worse outcomes and a 5-year survival rate of 20-30%. Recent advances mainly concern chemotherapy prior to surgical resection. The goal of pre-operative chemotherapy is to allow an early attack on systemic micrometastatic disease and, by downstaging the primary tumour, to increase the percentage of patients able to undergo curative resection. Pre-operative chemotherapy remains experimental, but several phase II and III studies have shown promising results. One approach involves systemic, pre-operative chemotherapy for resectable gastric cancer. This review focuses on the development of pre-operative chemotherapy as a component of the multimodal treatment of gastric cancer.

Preoperative chemotherapy (CT) and preoperative chemoradiation therapy (CRT) for resectable oesophageal cancer have both been shown to improve overall survival in meta-analyses. However there are no trials comparing these adjuvant therapies with each other. We assessed the outcomes after oesophagectomy following preoperative CT and preoperative CRT in a randomised phase II trial for resectable adenocarcinoma of the oesophagus and gastro-oesophageal junction

症例は66歳の男性で, 慢性B型肝炎のため経過観察中, 2006年2月,#12腹腔内リンパ節腫大を指摘され, 内視鏡検査で胃噴門直下に4cm大の1型腫瘍を認め乳頭状腺癌と診断された. 腫瘍マーカーはAlpha-fetoprotein (以下, AFP) が333ng/mlと高値であった. T2N3M0: stage IVの診断で化学療法を行った. TS-1(120mg/日)をday 1～14, day 1およびday8にDo-cetaxel(60mg/日), CDDP (10mg/日) をday1～5, 8～12に経静脈投与した. 画像上PRが得られ, AFP値も45ng/mlと低下し, 胃全摘を行った. 病理組織学的診断では原発巣に癌の遺残はなく, 郭清リンパ節にもGrade 2の効果が得られた. そのうち, 1個にのみ腫瘍の残存を認め, AFP染色陽性であった. TS-1による補助化学療法を3コース施行し, 術後14か月経過した現在再発はない. 化学療法が奏効したAFP産生胃癌の1例を報告する.

The multi-disciplinary approach, including surgery, chemotherapy, endocrine therapy and radiation therapy, has become the standard treatment for primary breast cancer patients. The indication of pre-operative chemotherapy has been extended to women with potentially operable breast cancer based on the results of large randomized studies and has become an attractive option that extends the chance of breast conservation. The clinical and pathological responses to pre-operative chemotherapy correlates with long-term outcome. The anthracycline-containing regimen is now considered the standard. Sequential administration of non-cross-resistant drugs, namely taxanes, improves local tumor response but its long-term benefit has been controversial. Prediction of response to pre-operative chemotherapy still remains a challenge. Identification of useful predictive markers and development of molecular-targeted drugs is the key to individualized therapy in the future.

症例は74歳の男性で, 主訴は全身倦怠感. 内視鏡検査で, 噴門より胃体下部に及ぶ2型病変を認めた. 生検の結果, 腺癌と診断したが, 一部の検体では扁平上皮癌を認めた. 腹部CTで膵臓への直接浸潤ならびにリンパ節#12Pに転移を認めた. Downstagingを目的にTS-1/CDDPによる術前化学療法を3コース施行した. CT画像による効果判定はNCであった. 胃全摘, 脾摘, 膵体尾部切除術を施行. 膵への直接浸潤を認めたが, 腹膜播種を認めず, Stage IV, 根治度はBであった. 病理組織学的検査では, 扁平上皮癌成分のみ認め, 腺癌成分を認めず, 腺扁平上皮癌の腺癌成分が術前化学療法により消失したものと考えられた. 腺癌成分と扁平上皮癌成分では, 化学療法に対する感受性が異なる可能性が示唆された.

Resume La chimiotherapie preoperatoire des cancers bronchiques non a petites cellules avait le double but de detruire les micrometastases et d’augmenter la resecabilite des tumeurs. Les essais de Rosell et de Roth etaient positifs en faveur de l’association mais avaient de faible effectif. Dans l’essai francais, la survie globale n’etait pas differente pour l’ensemble des patients mais l’etait dans les stades precoces. Les resultats preliminaires de l’essai du SWOG objectivent une difference de 6 % a 2 ans non significative. L’essai EORTC 08941, dans les tumeurs IIIAN2 non resecables, ne montrait pas de difference dans la comparaison de la chirurgie a la radiotherapie apres chimiotherapie d’induction. L’essai INT-0139 etudiait l’apport de la chirurgie apres chimio-radiotherapie d’induction par rapport a l’association exclusive chimio-radiotherapie. Il n’y avait pas de difference entre les 2 strategies mais l’analyse par sous-groupes indique que certains groupes pourraient beneficier de la triple association. Deux essais sont en attente de publications. Le petit nombre de patients finalement inclus par essai conduira a une meta-analyse pour acquerir une opinion definitive. L’association chirurgie et chimiotherapie va devenir un standard, dans les stades II. Seul reste en discussion le meilleur moment, pre ou postoperatoire. Dans l’objectif initial, seule la destruction des micrometastases est actuellement confortee.

522 Background: PUC is characterized by E-cadherin loss, diffuse growth pattern and aggressive natural history. Management of this entity is controversial. This retrospective study aims to evaluate the impact of PUC histology on clinical outcomes with ctx compared to UC-NOS. Methods: Consecutive cases of nonmetastatic PUC were identified as either (1) localized disease (LD: cT2-3 cN0) or (2) locally-advanced (LA: fixed bladder or radiographic nodal disease). All cases were reviewed by a GU pathologist to confirm PUC histology per WHO classification (2016). A separate cohort of neoadjuvant(NAC)-treated UC-NOS (Tully et al, ASCO GU 2014) served as comparator for clinical outcomes. Kaplan-Meier estimates and logrank test were used for analysis of recurrence free (RFS) and overall survival (OS) defined from date of cystectomy (RC). Results: Between 2000 and 2017, eighty one PUC were identified, with median age of 65 years (range: 22 - 84) and 65% male. Thirty patients (pts) had up-front RC; 51 pts had ctx. In the former group, all pts had LD but upstaging was seen on post-op pathology: 63% pT3, 17% pT4 and 37% pN+. Among ctx pts, 33/51(65%) were LD and had NAC: 70% had ctx doublet and 24% triplet; 82% had 4 cycles and 18% had up to 6 cycles. Response ( < pT2 pN0) was seen in 7/33(22%), four (12%) of which had no residual disease (pCR). Six RC were aborted after NAC for pT4b disease. NAC response was not associated superior RFS (NR vs. 17.3 months; HR 0.52 95% CI 0.18 – 1.47, p = .218) or OS (41.3 vs. 25.5 months; HR 0.65 95% CI 0.23 – 1.87, p = .428). Compared to UC-NOS, PUC responders had significantly inferior outcomes (table). In LA cohort, majority had triplet chemotherapy (72%) and up to 6 cycles (89%). Response was seen in 4/18(22%) pts, with two pCR (11%). Five RC were aborted for pT4b disease. Median RFS and OS were 5.8 and 10.5 months, respectively, with 19% alive at 2-years. Most common sites of recurrence/progression for PUC were peritoneal (42%) and locoregional invasion (26%). Conclusions: Outcomes for PUC are poor with conventional NAC-RC approach. [Table: see text]

95 Background: Peritoneal lavage cytology of positive and localized peritoneum metastasis of gastric cancer (GC) are defined as CY1 and P1 in the 14th edition of the Japanese Classification of GC. Patients (pts) with CY1 and/or P1 have poor prognosis after removing all macroscopically visible disease by standard gastrectomy followed by S1. The aim of this study was to investigate the efficacy of pre-operative chemotherapy (Pre-Cx) in patients with CY1 and/or P1. Methods: We retrospectively reviewed the GC pts who were diagnosed to have CY1 and/or P1 at 34 institutions participating in the Stomach Cancer Group of Japan Clinical Oncology Group between 2007 and 2012. Inclusion criteria were: no distant metastasis other than CY1 or P1, no prior treatment for GC. The subjects were divided to two groups according to treatment strategy with/without Pre-Cx before surgery. In the Pre-Cx group, status of CY and P was diagnosed by laparoscopy before and after Pre-Cx, and indication of surgical resection was decided by each physician. Results: A total of 824 pts were collected from 34 institutions. Of the 713 eligible pts, 150 pts received Pre-Cx (Pre-Cx group) and 563 pts underwent surgery followed by Cx (Post-Cx group). Proportions of P0CY1/P1CY0/P1CY1 were 69/12/19% and 69/17/14% in the Pre- and Post-Cx. Cx regimen for Pre-Cx were S1 plus cisplatin/ docetaxel and cisplatin plus S1/others (n=90/37/23). In the Pre-Cx, 57 (38%) pts who achieved P0CY0 after Pre-Cx showed better survival than the remaining 92 pts (overall survival (OS), 31.0 vs. 19.9 months (M), HR=1.99, 95% CI 1.32-2.93, p=0.001). OS was 24.8 and 24.0 M in the Pre- and Post-Cx (HR 1.07; 95% CI 0.87-1.32, p=0.502). In multivariate analysis, P1CY1, over 65 years old and clinical N3 lymph node metastasis were identified as the independent prognostic factor for OS (p

14. ABSTRACT Purpose: To study possible associations between the MRI morphological patterns of the primary breast tumor and properties of the surrounding host tissue. Scope: Identification of such properties of host tissue may be useful in characterizing breast tissue for earlier stage breast cancers. Major findings: We have developed MRI algorithms necessary to measure signal enhancement ratios in non-tumor tissue using the existing database of patients who underwent neoadjuvant chemotherapy. Results: We found that change in uninvolved breast tissue volume with treatment was correlated with tumor phenotypes and was shown to be predictive of recurrence. Significance: Host tissue changes with treatment can potentially provide information about pre-cancerous tissue that may have applicability to risk assessment.

The original article to which this Erratum refers was published in Journal of Surgical Oncology (2005)89 (4) 263–264

Summary A patient presenting with advanced Wilm’s tumour was diagnosed as having inferior vena cava involvement with tumour thrombus extending up to the right atrium, and was treated with preoperative chemotherapy (vincristine, actinocymin D, epirubicin). Atrial and inferior vena cava thrombus disappeared and he underwent a successful nephrectomy.

The purpose of this study was to examine the feasibility of administering all chemotherapy pre-operatively to patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. 32 patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction were studied in a stepwise fashion in which combination chemotherapy with cisplatin, high-dose arabinoside and 5-fluorouracil was administered. In the first part, 15 patients were to receive three chemotherapy courses pre-operatively and two chemotherapy courses postoperatively. In the second part, the next 15 patients were to receive all five chemotherapy courses pre-operatively, provided there was an objective response after three courses. Endoscopic ultrasonography was also performed, when feasible, prior to chemotherapy and surgery, and in some patients sequentially between chemotherapy courses. All of the 14 assessable patients in the first group tolerated all three courses of pre-operative chemotherapy, and 86% of patients in this group completed all protocol chemotherapy. In the second group, 9 of 18 (50%) assessable patients tolerated all five courses of preoperative chemotherapy, and 100% of patients in this group received all protocol chemotherapy. The median number of chemotherapy courses for the entire group (32 patients) was five (range one to five). Forty-one per cent ( 13 32 ) of patients had a major response to chemotherapy. Sixty-nine per cent (or 76% of 29 patients taken to surgery) had a curative resection. One patient had a pathological complete response. The median survival time of 32 patients was 17 months (range 2–36+ months). 14 patients (37%) remain alive at a median follow-up time of 26+ months. There was a correlation between endoscopie ultrasonographic tumour and nodal stage and pathological tumour and nodal stages in 16 patients. The tumour stage correlation was higher (75%) than the nodal stage correlation (62%). Our data suggest that it is feasible to administer five courses of cisplatin-based chemotherapy to patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. More effective chemotherapy regimens that might result in higher pathological complete response rates and acceptable toxic effects are needed.

9020 Aim: To evaluate QL during the first 2 years follow-up in patients randomised to receive 3 cycles of platinum-based chemotherapy (CT-S) prior to surgical resection of NSCLC compared to those receiving surgery alone (S). Methods: A total of 519 patients were entered into the LU22 trial from 70 centres in the UK, The Netherlands, Germany and Belgium. All patients were asked to complete the SF-36 QL questionnaire prior to randomisation and at 6 and 12 months then annually to 5 years. The scores from the SF-36 questionnaire were combined into 8 domains and also summarised as physical component summary (PCS) and mental component summary (MCS). The 6,12 and 24 month PCS and MCS scores were analysed using multivariable regression to identify prognostic factors and investigate the difference between the regimens. Results: 82% patients completed QL at baseline, and compliance at 6, 12 and 24 months was 59%, 60% and 67% respectively. Median age was 63 (range 25 to 79 years) and 72% were male. At 6 months patients in the S group reported somewhat better functioning in all domains except general health and mental health, but no differences were seen at 12 or 24 months. The regression analyses indicated that better physical health outcomes (PCS) were predicted by baseline PCS and MCS at all follow-up points (all p [Table: see text]

4512 Background: Optimal management of operable localised oesophageal carcinoma remains to be determined. The debate is fuelled by some positive individual trials showing a benefit of preoperative chemotherapy (CT+S) or preoperative chemo-radiotherapy (CRT+S) over surgery alone (S). Our group has initiated an individual patient data-based meta-analysis to quantify the potential benefit of CT+S over S. Methods: The methodology used for trial identification and data analysis has been previously reported. The primary endpoint was overall survival (OS). The secondary endpoints were disease-free-survival (DFS) analyzed with a 6 months landmark method, tumour resectability (complete resection rate) and post-operative mortality. The logrank-test, stratified by trial, and hazard ratio (HR) were used for comparison. Subgroup analyses by age, sex, performance status, and histologic type were prospectively planned. Results: Twelve eligible randomized trials (2,284 patients) were identified. Individual patient data from 9 trials (2,102 patients) with a median follow-up of 5.3 years were available for the OS analysis. There was a statistically significant OS benefit in favour of CT+S (HR=0.87, 95% CI 0.79–0.95, p=0.003) translating into a 5-year absolute OS increase of 4% (from 16 to 20%). Based on 7 trials (1,849 patients), the HR for DFS was 0.82 (95% CI 0.74–0.91, p=0.001) in favour of CT+S, representing a 5-year absolute DFS benefit of 4% (from 6 to 10%). The complete resection rate across 8 trials (1,933 patients) was significantly greater in the CT+S arm (67%) compared to the S arm (62%) (OR=0.81, 95% CI 0.67–0.98, p=0.03). No difference was seen in postoperative death (6.7%). No interaction between treatment effect and patients characteristics was seen. Conclusions: Individual patient data-based meta-analysis represents the highest level of evidence and this study shows a small but significant overall and disease-free survival benefit in favour of preoperative chemotherapy over surgery alone. Unrestricted grants from LNCC and Sanofi-Aventis. No significant financial relationships to disclose.

7518 Aims: Although surgery offers the best chance of cure for patients with NSCLC, the overall 5-year survival rate is modest, and improvements are urgently required. This intergroup trial was designed to investigate whether, in patients with operable NSCLC of any stage, neo-adjuvant platinum-based chemotherapy prior to surgery would improve outcomes. Methods: Patients were randomised to receive either surgery alone (S), or 3 cycles of platinum-based chemotherapy prior to surgery (CT-S). Results: 519 patients were randomised (261 S, 258 CT-S) from 70 centres in the UK, the Netherlands, Germany and Belgium. The median age of the patients was 63 years, 72% were male, 59% were PS 0, and 50% had squamous cell histology. The majority were clinical stage I (17% Ia, 45% Ib, 3% IIa, 29% IIb, 7% IIIa), and 12% received mitomycin/vinblastine/cisplatin (MVP), 7% mitomycin/ifosfamide/cisplatin (MIC), 45% vinorelbine/cisplatin, 12% carboplatin/docetaxel, and 25% cisplatin/gemcitabine. The trial showed that neo-adjuvant chemotherapy was feasible (76% of patients received all 3 cycles of chemotherapy), resulted in a good response rate (4% CR, 45% PR, and only 2% PD), appeared to cause down-staging in about 20% of patients, and did not affect the type of surgery performed, the post-operative complication rate, or quality of life. However, there was no evidence of a benefit in terms of progression-free survival (282 events, HR 0.98, 95% CI 0.77,1.23) or overall survival (232 deaths, HR 1.04, 95% CI 0.81, 1.35), and more patients were reported as having brain metastases in the CT-S group (30 CT-S vs 11 S patients). Exploratory analyses showed no evidence that any subgroup of patients benefited from the addition of neo-adjuvant chemotherapy. Conclusions: This intergroup trial, which is the largest trial of neo-adjuvant chemotherapy in patients with resectable NSCLC, indicated that the addition of neo-adjuvant platinum-based chemotherapy did not lead to a benefit in overall survival. However, a 19% survival benefit or a 35% detriment cannot be excluded and this result needs to be considered in the context of all other relevant randomised trials of neo-adjuvant chemotherapy for NSCLC. [Table: see text]

3500 Background: After resection of LM, 5y survival is 30%, but cancer recurrence is frequent. The benefit of combining surgery and CT has not yet formally been proven. Methods: This study evaluates the value of pre- and postoperative CT in patients with potentially resectable liver metastases from colorectal cancer. Between September 2000 and July 2004, 364 patients were randomized between peri-operative FOLFOX4 (oxaliplatin 85mg/m2 and LV5FU2), 6 cycles before and 6 cycles after surgery (182 patients), and surgery alone (182 patients). The primary endpoint was progression free survival. The purpose of this analysis was to evaluate tumor response to pre-operative treatment and determine if CT induces a tumor size reduction. Results: Baseline characteristics were similar in both arms: median age: 62.5 yrs, prior adjuvant CT: 41.8%, 1 to 3 metastases: 92.3%, T3 or T4: 80.8%. In the CT arm, 97.7% of the patients were documented to have completed pre-operative CT (81.5% received 6 preoperative cycles). 28.9% of the patients who started pre-operative CT required a dose reduction. Of all patients entered in the trial, 88.3% and 94.9% underwent surgery in the CT and surgery arms, respectively. Resection was achieved in 95.6% of the patients operated (84.4% of all patients) in the CT arm, and 89.2% of the patients operated (84.7% of all patients) in the surgery arm. As previously reported, preoperative chemotherapy was safely administered. From imaging data (CT scan), median sum of largest diameters of lesions was 45 mm [Q1-Q3:28.0–70.0] (both arms) before treatment and decreased to 30 mm [Q1-Q3: 15.0–55.0] after CT (median relative difference of 29.7%). At pathological examination, median sum of largest diameters of lesions was 34.5 mm [Q1-Q3:20.0–53.0] in the CT arm and 45 mm [Q1-Q3: 29.0–69.0] in the surgery arm. Conclusions: CT scan measurements were consistent with those performed at pathological examination. Pre-operative CT with 6 cycles of FOLFOX4 resulted in a decrease in diameter of lesions. Since size of metastases at time of surgery is known to have an impact on survival, it is possible that preoperative chemotherapy will improve survival. Survival data should be available at the end of 2006. No significant financial relationships to disclose.

14011 Background: The MRC OE02 study demonstrated pre-operative chemotherapy in patients with potentially operable oesophageal cancer improved survival. Pre-operative chemotherapy has been widely adopted in the UK. At our institution for the past 5 years patients with operable oesophageal cancer have routinely been given pre-operative chemotherapy with 3 cycles of Epirubicin, Cisplatin and Protracted Venous Infusion (PVI) 5FU (ECF). Recently, PVI 5FU has been replaced by Capecitabine (ECX). Methods: From March 2000 to October 2005, patients with operable oesophageal carcinoma have received 3 cycles of ECF or ECX (Epirubicin 50mg/m2, Cisplatin 60mg/m2, and PVI 5FU 200mg/m2 per day or Capecitabine 625mg/m2 po bd for 21 days). Disease response was assessed by CT scan and surgery was performed 4–6 weeks after completion of chemotherapy. Results: 59 patients received neo-adjuvant chemotherapy (48 received ECF, 11 ECX). Median age was 64. Fifty-three patients (89.8%) completed the planned 3 cycles of chemotherapy. WHO grade 3 or 4 toxicity occurred in 7 patients (11.8%): 6 haematological with 1 toxic death among them (1.7%) and 1 mucositis. Forty-four of 49 patients (89.7%) with dysphagia reported improvement of their symptoms as a result of chemotherapy. Fifty-two patients (88.1%) proceeded to surgery of which 47 (90.3%) underwent complete tumour resection, 4 patients (7.7%) were found to have inoperable/metastatic disease and 1 patient had incomplete excision (1.9%). Median follow-up was 26.8 months with overall median survival of 36.2 months and a 2-year survival of 63.2%. Thirty-four (57.6%) patients remain alive to date of which, 30 are disease-free and 4 are alive with recurrent disease. Conclusions: These encouraging results demonstrate that 3 cycles of preoperative ECF/ECX chemotherapy in patients with operable oesophageal cancer allow surgery to be safely performed in the vast majority of patients and our 2-year survival compare favourably with previously reported series. These results suggest that 3 cycles of pre-operative treatment with ECF/ECX chemotherapy may improve survival in this group of patients and is worthy of further research. No significant financial relationships to disclose.

3528 Background: After resection of LM, 5y survival is 30%, but cancer recurrence is frequent. The benefit of combining surgery and CT is not yet formally proven. Methods: This study evaluates pre- and postoperative CT. Between September 2000 and July 2004, 364 patients with potentially resectable liver metastases from colorectal cancer were randomized between peri-operative FOLFOX4 (oxaliplatin 85mg/m2 and LV5FU2), 6 cycles before and 6 cycles after surgery, and surgery alone. The primary endpoint was disease-free survival. Safety was a secondary end point. Results: We report the interim safety results of the first 346 patients with at least 3 months follow-up post surgery (174 patients in the CT arm and 172 in the surgery arm). Median follow up is 17 months. Baseline characteristics were similar in both arms. In the CT arm, 84.8% of the patients were documented to have completed CT (6 preoperative cycles). 28.2% of the patients who started CT required a dose reduction. Grade ≥3 diarrhea was reported in ...