First report of a complete pathological response of a pelvic GIST treated with imatinib as neoadjuvant therapy.
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Pathologic complete response and survival advantage in esophageal cancer: old news.
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Chemotherapy, Adjuvant↗
Is pathologic complete response a valid surrogate parameter of treatment efficacy in HER2 positive breast cancer patients undergoing primary chemotherapy plus trastuzamab?
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Antibodies, Monoclonal↗
[A case of testicular choriocarcinoma achieving pathological complete response by "COMPE" chemotherapy, consisting of cisplatin, vincristine, methotrexate, peplomycin, and etoposide].
We report a case of pure choriocarcinoma of the left testis in a 27-year-old male. He consulted a physician with left back pain in August, 1990. Intravenous pyelography (IVP) revealed left hydronephrosis. Abnormal computerized tomography (CT) revealed para-aortic lymph node swelling. The chest X-ray revealed bilateral multiple coin lesions. The genital examination revealed a left testicular nodule 8 mm in diameter. Left high inguinal orchiectomy was performed. Histopathological diagnosis was pure choriocarcinoma. After 4 courses of the PVB (cisplatin, vinblastine, bleomycin) therapy, tumor regression rate of the pulmonary metastases was 41.9%. He was transferred to our hospital on December 3, 1990 and was admitted 3 days later. "COMPE" chemotherapy, consisting of cisplatin, vincristine, methotrexate, peplomycin, and etoposide, was administered. After seven courses of "COMPE" chemotherapy, he achieved a partial response (the regression rate of the pulmonary metastases and the retroperitoneal lymph node metastasis were 78.8% and 69.1%, respectively) and the residual masses in the lungs and the retroperitoneum were removed. Necrosis and xanthogranulomatous fibrosis were found in the resected material. The patient showed no evidence of disease one year after thoracotomy.
Adult↗
[A case of adult pure yolk sac tumor of the testis achieving pathological complete response by chemotherapy].
We report a case of pure yolk sac tumor of the left testis in a 22-year-old male. He consulted a physician with left back pain and induration of his left scrotal content in December, 1992. Intravenous pyelography (IVP) revealed left hydronephrosis. Computerized tomography (CT) revealed para-aortic lymph node swelling and lung metastases. Left high inguinal orchiectomy was performed. Histopathological diagnosis was pure yolk sac tumor. After two courses of "COMPE" chemotherapy consisting of cisplatin, vincristine, methotrexate, peplomycin and etoposide, two courses of "high dose "COMPE" chemotherapy and three courses of "high dose COME" chemotherapy without peplomycin, he achieved a partial response (the regression rate of the pulmonary metastases and the retroperitoneal lymph node metastasis were 100% and 96.0% on CT, respectively) and the residual masses in the retroperitoneum were removed. Necrosis and xanthogranulomatous fibrosis were found in the resected material. The patient showed no evidence of disease two years after chemotherapy.
Adult↗
Pilot study of concurrent cisplatin, 5-fluorouracil, and external beam radiotherapy prior to radical surgery +/- intraoperative electron beam radiotherapy in locally advanced cervical cancer.
PURPOSE: The purpose of this study was to describe the feasibility of a combined preoperative chemoradiation program followed by radical surgery in advanced cervical cancer. MATERIALS AND METHODS: From February 1988 to April 1997, 40 patients with carcinoma of the cervix were treated with preoperative external beam radiotherapy to 45 Gy in 5 weeks. Patients received concurrent continuous infusion cisplatin (20 mg/m2) and 5-fluorouracil (1500 mg) chemotherapy during the first (days 1-4) and fifth (days 22-25) weeks of the radiation course. Radical surgery was performed 4-6 weeks after the completion of the preoperative treatment. Intraoperative radiotherapy was given to 20 patients, based on intraoperative assessment. RESULTS: Toxicity associated with chemoradiation was usually mild except in two patients who presented WHO grade 4 bone marrow aplasia. Three patients developed postoperative ureterovaginal fistula, and five patients developed long-term hydronephrosis that needed ureteral stenting. Clinical response was observed in 95% of the patients (55% complete response). The analysis of the surgical specimens revealed complete pathological response in 67.5% of the cases and partial pathological response in 32.5%. As expected, the degree of pathological response was predicted by the degree of clinical response (P = 0.001). Nine-year local control, distant metastases-free survival, disease-free survival, and overall survival were 86, 84, 81, and 85%, respectively. Patients displaying a complete pathological response had statistically significant improved local control (P = 0.004), distant metastases-free survival (P = 0.009), disease-free survival (P = 0.002), and overall survival (P = 0.038). CONCLUSIONS: Cisplatin plus 5-fluorouracil preoperative chemoradiation is active and usually well tolerated in locally advanced carcinoma of cervix, inducing a high rate of clinical and pathological complete responses. When this therapy is followed by radical surgery, the local control rates are excellent, even in patients with advanced stages or poor response. These improved local control rates may be achievable only through extensive surgical resection, with a parallel increase in the complication rates.
Actuarial Analysis↗
FDG-PET in staging and restaging non-small cell lung cancer after neoadjuvant chemoradiotherapy: correlation with histopathology.
This study was performed to investigate the utility of FDG-PET for: (1) initial staging, and (2) restaging of the primary and mediastinal nodal lesions 2 weeks after the completion of preoperative chemoradiotherapy in patients with stage III non-small cell lung cancer (NSCLC). Twenty-six patients with histologically confirmed stage III NSCLC were accrued to this study from April 1993 to July 1998. They included 21 with stage IIIA (N2) NSCLC who were enrolled into an institutional phase II study, and 5 patients with a highly selected subset of stage IIIB disease characterized by the presence of microscopic metastatic disease in contralateral mediastinal lymph nodes who were also treated with preoperative chemoradiotherapy; N3 lesions (n=3) and minimal T4 lesions. Demographic characteristics included median age 62 years (a range from 47 to 73) and gender ratio of male 15 to female 11. Histologic types of tumor consisted of squamous cell carcinoma 6, adenocarcinoma 11, large cell carcinoma 5, and non-small cell carcinoma 4. All patients had FDG-PET imaging of the chest before the initiation and 2 weeks after completion of preoperative therapy. The FDG-PET images were evaluated qualitatively for uptake at the primary tumor sites and mediastinal lymph nodes. Standard uptake values (SUVs) were also calculated for the primary tumors and all PET findings were correlated with surgical histopathologic data. Preoperative chemoradiotherapy resulted in complete pathologic response in 8 of 26 primary lesions. By qualitative analysis, 96% of these tumors showed level 3 or 4 uptake before preoperative chemoradiotherapy. After chemoradiotherapy, 57% (15/26) of patients showed at least a one level decrease in uptake, and the sensitivity and specificity of FDG-PET for differentiating residual tumor from pathologic complete response were 67% (12/18) and 63% (5/8). Mean SUV was 14.87+/-7.11 at baseline and decreased to 5.72+/-3.35 after chemoradiotherapy (n=21, P<0.00001). When a value of 3.0 was used as the SUV cut-off, sensitivity and specificity were 88 and 67%, respectively. The mean values of visual intensity were 3.87+/-0.35 and 3.8+/-0.51 for patients who achieved pathologic complete response (n=8) and for those who showed residual cancer after the preoperative therapy (n=18), respectively. The mean SUVs were 16.97+/-8.52 and 14.03+/-6.61 for patients who achieved pathologic complete response (n=6) and for those who showed residual cancer (n=15) after the preoperative therapy, respectively. Therefore, the degree of FDG uptake before preoperative chemoradiotherapy did not provide predictive value for subsequent tumor response. For mediastinal initial staging, the sensitivity and specificity of FDG-PET were 75 and 90.5%. The sensitivity and specificity of FDG-PET for mediastinal restaging were 58.0 and 93.0%. These results indicate that FDG-PET is useful for monitoring the therapeutic effect of neoadjuvant chemoradiotherapy in patients with stage III NSCLC. For the primary lesions, SUV based analysis has high sensitivity but limited specificity for detecting residual tumor. In contrast, for restaging of mediastinal lymph nodes, FDG-PET is highly specific, but has limited sensitivity.
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Neoadjuvant intra-arterial chemotherapy in the treatment of advanced transitional cell carcinoma of the bladder: results and followup.
The long-term results of regional chemotherapy plus intra-arterial cisplatin with or without doxorubicin as an adjuvant before cystectomy and urinary diversion in patients with invasive transitional cell carcinoma of the bladder were evaluated. A total of 27 patients with T3aNxMo (8), T3bNxMo (14) and T4NxMo (5) disease participated in a phase II trial completed in 1985. Of the patients 19 received cisplatin and doxorubicin intra-arterially, and cyclophosphamide intravenously, and the remaining 8 received 70 to 100 mg. per m.2 cisplatin intra-arterially. A total of 19 patients underwent cystectomy after chemotherapy. Patients in this group had a pathological complete response (no evidence of disease after surgical restaging) or the presence of residual disease at operation that could (surgical complete response) or could not (pathological partial response) be completely resected. Of the 19 patients undergoing cystectomy surgical complete response was observed in 47.4%, pathological complete response in 26.3% and pathological partial response in 26.3%. At a median followup of 27 months for the group 66% of the patients with a surgical complete response, 100% with a pathological complete response and 40% with a pathological partial response were alive with no evidence of disease. The over-all survival for patients with a pathological or surgical complete response is 76.9%. In the patients not operated upon because of persistent or advanced disease after chemotherapy survival was brief (less than 4 months). Prolonged survival in patients achieving a pathological or surgical complete response with neoadjuvant chemotherapy occurs, and this modality may have a role in patients with invasive tumors.
Aged↗
Can molecular imaging predict response to preoperative chemoradiation in patients with rectal cancer? A Fox Chase Cancer Center prospective experience.
This study was undertaken to correlate change in fluorine-18 fluorodeoxyglucose positron emission tomography ((18)FDG-PET) uptake with response to combined-modality neoadjuvant therapy in patients with locally advanced rectal cancer. Twenty patients (13 male; 7 female) underwent (18)FDG-PET scans before and 3 to 4 weeks after completion of chemoradiation before surgery. Staging by endoscopic ultrasound was T3/T4 (17/1); two patients were unable to undergo endorectal ultrasound. Fifteen patients had perirectal lymphadenopathy. Median radiation dose was 5,040 cGy (range, 4,500 to 5,500 cGy). All patients received continuous infusion 5-fluorouracil (or capecitabine) with radiation. Median pre- and post-chemoradiation standard uptake values were 9.4 (range, 3.6 to 37.0) and 3.05 (range, 0.5 to 8.2), respectively. Median percent standard uptake value decrease observed in the postchemoradiation PET scans was 71% (range, 7% to 95%). Six patients (30%) had pathologic complete response. Only two of six patients with postchemoradiation standard uptake values <or=2.5 had a complete pathologic response. The time from the end of radiation to surgery was marginally significant for predicting pathologic complete response (P = .12). Neoadjuvant combined-modality therapy resulted in decreased metabolic activity on PET. Because response to preoperative treatment predicts clinical outcome, the utility of midtreatment PET scans to guide treatment decisions should be further explored in larger clinical studies.
Adenocarcinoma↗
Docetaxel as neoadjuvant chemotherapy in patients with stage III breast cancer.
Optimal management of locally advanced breast cancer (stage III) generally includes a combination of primary chemotherapy followed by surgery (if feasible), and local radiotherapy and adjuvant chemotherapy with or without hormonal therapy. An ongoing phase II study is being performed to evaluate the use of 4 cycles of 100 mg/m2 of docetaxel (Taxotere) administered as a 1-hour intravenous infusion once every 3 weeks followed by surgery, 4 cycles of standard-dose doxorubicin/cyclophosphamide (Cytoxan, Neosar) chemotherapy, and radiation, with and without tamoxifen (Nolvadex) in patients with locally advanced breast cancer. Preliminary results from 33 patients included in this phase II study are reported here. A partial response was achieved in 22 patients (67%), with 6 patients (18%) experiencing a complete response with this regimen. One patient with a complete response was confirmed to have a complete pathologic response at the time of surgery. Febrile neutropenia was noted in 8 patients (24%) and in 8 of the 120 treatment cycles (7%) administered. Future trials aimed at increasing the number of pathologic complete responses in patients with stage III breast cancer may require the use of docetaxel in combination with other active agents or the use of dose-dense scheduling schemes.
Adult↗
Preoperative chemotherapy for esophageal cancer with paclitaxel and carboplatin: results of a phase II trial.
OBJECTIVE: Paclitaxel has one of the highest response rates when used as a single agent in patients with esophageal cancer. The combination of paclitaxel and carboplatin has been shown to be a well-tolerated and safe regimen in non-small cell lung cancer. The objective of this study was to determine the efficacy of preoperative paclitaxel and carboplatin in patients with carcinoma of the esophagus. PATIENTS AND METHODS: A phase II trial was initiated in January 1999 and concluded in January 2001. All patients had potentially resectable disease (including clinical T4 lesions). Patients with stage I disease and those with visceral metastases were excluded. All underwent preoperative computed tomography scanning and endosonography for staging. Paclitaxel (200 mg/m(2)) and carboplatin (area under the curve = 6) were given on days 1 and 22. Esophagectomy was carried out on weeks 6 to 8. RESULTS: Twenty-six (11 epidermoid, 15 adenocarcinoma) patients completed the trial. Median age was 61.5 and 85% were men. Preoperative staging showed: stage IIA, 6 patients; stage IIB, 1 patient; and stage III, 19 patients. All patients completed their preoperative chemotherapy. There was no unexpected chemotherapy-related toxicity. A major clinical response was achieved in 16 patients (61%: 19% complete, 42% partial). Resectability was 77% (20/26). A complete pathologic response was seen in 11% of all patients and in 25% of those with epidermoid cancer. Hospital mortality and morbidity were 4 and 27%, respectively. Overall 3-year survival was 48% (64% for resected patients, median not reached). All 6 unresectable patients died within 6 months of exploration. CONCLUSION: Paclitaxel-carboplatin combination is a safe and well-tolerated regimen for esophageal cancer with clinical response rates comparable to historical controls. This regimen may be especially suitable for patients with epidermoid cancer, who had a 25% pathological complete response in this report.
Adenocarcinoma↗
First-line high-dose sequential chemotherapy with rG-CSF and repeated blood stem cell transplantation in untreated inflammatory breast cancer: toxicity and response (PEGASE 02 trial).
Despite the generalization of induction chemotherapy and a better outcome for chemosensitive diseases, the prognosis of inflammatory breast cancer (IBC) is still poor. In this work, we evaluate response and toxicity of high-dose sequential chemotherapy with repeated blood stem cell (BSC) transplantation administered as initial treatment in 100 women with non-metastatic IBC. Ninety-five patients (five patients were evaluated as non-eligible) of median age 46 years (range 26-56) received four cycles of chemotherapy associating: cyclophosphamide (C) 6 g m(-2) - doxorubicin (D) 75 mg m(-2) cycle 1, C: 3 g m(-2) - D: 75 mg m(-2) cycle 2, C: 3 g m(-2) - D: 75 mg m(-2) - 5 FU 2500 mg m(-2) cycle 3 and 4. BSC were collected after cycle 1 or 2 and reinfused after cycle 3 and 4. rG-CSF was administered after the four cycles. Mastectomy and radiotherapy were planned after chemotherapy completion. Pathological response was considered as the first end point of this trial. A total of 366 cycles of chemotherapy were administered. Eighty-seven patients completed the four cycles and relative dose intensity was respectively 0.97 (range 0.4-1.04) and 0.96 (range 0.25-1.05) for C and D. Main toxicity was haematological with febrile neutropenia ranging from 26% to 51% of cycles; one death occurred during aplasia. Clinical response rate was 90% +/- 6%. Eighty-six patients underwent mastectomy in a median of 3.5 months (range 3-9) after the first cycle of chemotherapy; pathological complete response rate in breast was 32% +/- 10%. All patients were eligible to receive additional radiotherapy. High-dose chemotherapy with repeated BSC transplantation is feasible with acceptable toxicity in IBC. Pathological response rate is encouraging but has to be confirmed by final outcome.
Adenocarcinoma↗
Phase II evaluation of preoperative chemoradiation and postoperative adjuvant chemotherapy for squamous cell and adenocarcinoma of the esophagus.
PURPOSE: This phase II trial evaluated continuous-infusion cisplatin and fluorouracil (5-FU) with radiotherapy followed by esophagectomy. The objectives of this trial were to determine the complete pathologic response rate, survival rate, toxicity, pattern of failure, and feasibility of administering adjuvant chemotherapy in patients with resectable cancer of the esophagus treated with preoperative chemoradiation. PATIENTS AND METHODS: Patients were staged using computed tomography, endoscopic ultrasound, and laparoscopy. The preoperative treatment plan consisted of continuous intravenous infusion of cisplatin and 5-FU and a total dose of 44 Gy of radiation. Esophagogastrectomy was planned for approximately 4 weeks after the completion of chemoradiotherapy. Paclitaxel and cisplatin were administered as postoperative adjuvant therapy. RESULTS: Forty-two patients were enrolled onto the trial. Of the 39 patients who proceeded to surgery, 29 responded to preoperative treatment: 11 achieved pathologic complete response (CR) and 18 achieved a lower posttreatment stage. Five patients had no change in stage, whereas eight had progressive disease (four with distant metastases and four with increases in the T and N stages). At a median follow-up of 30.2 months, the median survival time has not been reached and the 2-year survival rate is 62%. The median survival of pathologic complete responders has not been reached, whereas the 2-year survival rate of this group is 91% compared with 51% in patients with complete tumor resection with residual tumor (P =.03). CONCLUSION: An excellent survival rate, comparable to that of our prior preoperative trial, was achieved with lower doses of preoperative cisplatin and 5-FU concurrent with radiotherapy.
Adenocarcinoma↗
Evaluation of pre- and postoperative chemotherapy for resectable adenocarcinoma of the esophagus or gastroesophageal junction.
Thirty-five consecutive patients with resectable adenocarcinoma of the esophagus or gastroesophageal junction were treated with two preoperative and three or four postoperative chemotherapy courses consisting of etoposide, fluorouracil, and cisplatin (EFP) to evaluate the rate of curative resection, clinical and pathologic response, toxic effects, and survival. One hundred thirty-seven courses with a median number of five courses (range, one to six) were administered. Preoperative EFP resulted in 17 (49%) major responses, including six patients who did not have carcinoma cells in the repeat endoscopic biopsy specimens and cytologic brushings. Among 32 patients who had surgery, 25 (78%) had curative resection, one patient had a complete pathologic response, and one had microscopic carcinoma in the resected specimen. Six patients had microscopic carcinoma at the resection margins and received postoperative radiotherapy. At a median follow-up of 20 months, the projected survival of 35 patients is 23 months (range, 6 to 33+). Fifteen patients died of their carcinomas, and 15 patients were alive (median follow-up, 20+ months; range, 15+ to 33+ months) with no evidence of relapse. There were no deaths related to chemotherapy, surgery, or radiotherapy. EFP-induced toxic reactions were moderate. Our data suggest that multiple courses of EFP are feasible. Future strategies for this disease should consider prolonged chemotherapy with regimens that result frequently in pathologic complete responses.
Adenocarcinoma↗
[Neoadjuvant chemotherapy for primary breast cancer].
OBJECTIVE: To evaluate the feasibility and effect of fluorouracil (5-Fu) in association with anthracycline-based regimen as neoadjuvant chemotherapy for primary breast cancer. METHODS: For one hundred and eleven primary breast cancer patients with 114 lesions who were to be operated, two to six cycles of 5-Fu (continuous infusion) in association with epirubicin or pirarubicin and cyclophosphamide (CEFci or CTFci regimen) were given before operation. The response rate, side effect and its relation with tumor characteristics were studied. RESULTS: The overall response rate was 87.7%, of which the complete clinical response was 39.5%, pathological complete response was 23.7%, only one patient (0.9%) showed progressive disease. The regimen containing pirarubicin was superior to epirubicin regimen in pathological complete response rate (P < 0.05). Alopecia was mild in pirarubicin regimen as compared with epirubicin regimen but neutropenia was more severe in pirarubicin regimen than that in epirubicin regimen. Hormonal receptor expressions were significantly related to treatment response, the pathological complete response rate was 33.3% in oestrogen or progestin receptor negative tumors, but it was 7.5% in the positive tumors (P < 0.005). No correlation was observed between treatment response and tumor size, as well as HER-2 expression. CONCLUSION: CTFci/CEFci regimen as neoadjuvant chemotherapy is effective and safe for primary breast cancer. CTFci regimen is superior to CEFci regimen in response rate. The patients with negative hormonal receptor are more sensitive to the neoadjuvant chemotherapy.
Antineoplastic Combined Chemotherapy Protocols↗
Preoperative chemoradiotherapy in locally advanced rectal cancer: Ramathibodi experience.
A retrospective study of the preoperative chemoradiotherapy in locally advanced rectal cancer performed at Ramathibodi Hospital. The median age of twelve patients was 52 years. The tumor locations (upper-, mid-, lower rectum) were 25%, 50% and 25%, respectively. Eleven patients had clinical stage 111 disease. All received concurrent 5-FU-based chemoradiotherapy followed by surgery (if resectable) and chemotherapy. The most common toxicity of preoperative treatment was gr. 1-2 diarrhea (58.3%). The response rate was 41.7%. Five patients (41.7%) underwent sphincter-sparing surgery. Four patients underwent AP resection. Twenty-five percent achieved pathological complete response. Pathological downstaging occurred in 33.3%. The remaining three patients had unresectable disease. With the median follow up of 13 months, five patients had progressive disease and one has expired. The local failure rate was 16.7%. The one-year recurrence-free survival was 75%. The authors conclude that preoperative chemoradiotherapy is an effective treatment with favorable outcome in locally advanced rectal cancer.
Adult↗
DNA ploidy and S-phase fraction as predictive factors of response and outcome following neoadjuvant methotrexate, vinblastine, epirubicin and cisplatin (M-VEC) chemotherapy for invasive bladder cancer.
OBJECTIVE: To investigate the value of DNA ploidy and S-phase fraction (SPF) as factors that could predict response and outcome of invasive transitional cell carcinoma (TCC) of the bladder to neoadjuvant methotrexate, vinblastine, epirubicin and cisplatin (MVEC) chemotherapy. MATERIALS AND METHODS: Twenty-four patients with localized invasive TCC of the bladder (stages T3 to T4a, NoMo) were treated with neoadjuvant MVEC chemotherapy. DNA flow cytometry was performed in paraffin-embedded tissue obtained by transurethral resection before chemotherapy. Radical cystectomy specimens were utilized for complete pathologic staging. The tumors were subdivided into high- and low-SPF tumors according to their SPF value. DNA ploidy status was evaluated into two groups (diploidy and nondiploidy). RESULTS: DNA ploidy was not correlated to the response to chemotherapy (p = 0.67), and overall or disease-free survival (p = 0.27 and p = 0.69, respectively). Major response (pathologic complete response and partial response) was more often found in the high SPF group than among tumors with low SPF (p = 0.02). High SPF tumors were significantly associated with increased overall and disease-free survival (p = 0.0056 and p = 0.0059, respectively). CONCLUSION: A high SPF, but not DNA ploidy, may be helpful to identify patient likely to respond and survive longer following neoadjuvant MVEC chemotherapy in the treatment of invasive bladder cancer.
Aged↗
Epirubicin, cisplatin and continuous infusion 5-fluorouracil (ECF) as neoadjuvant chemotherapy in gastro-oesophageal cancer.
High response rates have been reported in the treatment of advanced gastric cancer with epirubicin, cisplatin and continuous infusion 5-fluorouracil (ECF), including instances of unresectable disease being rendered operable by chemotherapy. We report our experience with ECF as neoadjuvant treatment in gastric and lower oesophageal carcinoma. Twenty-seven patients were treated, of whom ten (37%) had carcinoma of the stomach and 17 (63%) tumours of the lower oesophagus. Histology in the majority of cases, 21 (78%), was adenocarcinoma. Before chemotherapy ten patients (37%) had evidence of initially unresectable locally advanced disease, 16 (59%) had localised disease only and one patient (4%) had a localised primary with a single liver metastasis. Epirubicin (50 mg m(-2) i.v.) and cisplatin (60 mg m(-2) i.v.) were administered every 3 weeks for four cycles together with a continuous 12 week infusion of 5-fluorouracil (200 mg m(-2) day(-1)). Fifteen of 24 assessable patients (62%) had symptomatic improvement on chemotherapy. On combined surgical and/or radiological assessment, 15 of the 27 patients (56%) had objective evidence of tumour response. In all patients assessment for radical surgery was made following chemotherapy. Eighteen patients (67%) proceeded to operation: of these, 11 had complete resection of their disease, one had a histologically incomplete resection and six were found to have unresectable disease. No pathological complete responses were observed. Only one of the ten patients with locally advanced disease achieved complete surgical resection after chemotherapy. At a median follow-up of 36 months from date of diagnosis (range 30-47 months), 19 of the 27 patients (70%) have died. Of 11 patients who had a complete surgical resection, one died post-operatively, three have subsequently relapsed (of whom two have died) and seven remain disease free. Toxicity from treatment was mild and included emesis, myelosuppression, stomatitis and exfoliation. Myelosuppression caused modification of treatment in 14 of 108 chemotherapy cycles (13%). There was one surgical death but no chemotherapy-related deaths. These early results show encouraging symptomatic and objective responses of gastro-oesophageal carcinoma to ECF, but provide no instances of ECF achieving complete pathological response. Only randomised trials can establish the role of neoadjuvant ECF chemotherapy in both initially resectable and unresectable carcinoma of the stomach and lower oesophagus.
Adult↗