scholarly journals Image-Guided Brachytherapy for Salvage Reirradiation: A Systematic Review

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1226
Author(s):  
Sophie Bockel ◽  
Sophie Espenel ◽  
Roger Sun ◽  
Isabelle Dumas ◽  
Sébastien Gouy ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Local Control ◽  
Large Scale ◽  
Salvage Surgery ◽  
Curative Intent ◽  
Suitable Alternative ◽  
Clinical Issue ◽  
Image Guided ◽  
Gynecological Malignancies ◽  
Grade 3

Background: Local recurrence in gynecological malignancies occurring in a previously irradiated field is a challenging clinical issue. The most frequent curative-intent treatment is salvage surgery. Reirradiation, using three-dimensional image-guided brachytherapy (3D-IGBT), might be a suitable alternative. We reviewed recent literature concerning 3D-IGBT for reirradiation in the context of local recurrences from gynecological malignancies. Methods: We conducted a large-scale literature research, and 15 original studies, responding to our research criteria, were finally selected. Results: Local control rates ranged from 44% to 71.4% at 2–5 years, and overall survival rates ranged from 39.5% to 78% at 2–5 years. Grade ≥3 toxicities ranged from 1.7% to 50%, with only one study reporting a grade 5 event. Results in terms of outcome and toxicities were highly variable depending on studies. Several studies suggested that local control could be improved with 2 Gy equivalent doses >40 Gy. Conclusion: IGBT appears to be a feasible alternative to salvage surgery in inoperable patients or patients refusing surgery, with an acceptable outcome for patients who have no other curative therapeutic options, however at a high cost of long-term grade ≥3 toxicities in some studies. We recommend that patients with local recurrence from gynecologic neoplasm occurring in previously irradiated fields should be referred to highly experienced expert centers. Centralization of data and large-scale multicentric international prospective trials are warranted. Efforts should be made to improve local control while limiting the risk of toxicities.

scholarly journals Preoperative surgical risk stratification in osteosarcoma based on the proximity to the major vessels

2019 ◽  
Vol 101-B (8) ◽  
pp. 1024-1031 ◽  
Author(s):  
T. Fujiwara ◽  
M. R. Medellin ◽  
A. Sambri ◽  
Y. Tsuda ◽  
J. Balko ◽  
...  
Keyword(s):  
Overall Survival ◽  
Local Recurrence ◽  
Blood Vessels ◽  
Limb Salvage ◽  
Local Control ◽  
Salvage Surgery ◽  
Limb Salvage Surgery ◽  
Poor Prognostic Factor ◽  
Type 3

Aims The aim of this study was to determine the risk of local recurrence and survival in patients with osteosarcoma based on the proximity of the tumour to the major vessels. Patients and Methods A total of 226 patients with high-grade non-metastatic osteosarcoma in the limbs were investigated. Median age at diagnosis was 15 years (4 to 67) with the ratio of male to female patients being 1.5:1. The most common site of the tumour was the femur (n = 103) followed by tibia (n = 66). The vascular proximity was categorized based on the preoperative MRI after neoadjuvant chemotherapy into four types: type 1 > 5 mm; type 2 ≤ 5 mm, > 0 mm; type 3 attached; type 4 surrounded. Results Limb salvage rate based on the proximity type was 92%, 88%, 51%, and 0% for types 1 to 4, respectively, and the overall survival at five years was 82%, 77%, 57%, and 67%, respectively (p < 0.001). Local recurrence rate in patients with limb-salvage surgery was 7%, 8%, and 22% for the types 1 to 3, respectively (p = 0.041), and local recurrence at the perivascular area was observed in 1% and 4% for type 2 and 3, respectively. The mean microscopic margin to the major vessels was 6.9 mm, 3.0 mm, and 1.4 mm for types 1 to 3, respectively. In type 3, local recurrence-free survival with limb salvage was significantly poorer compared with amputation (p = 0.025), while the latter offered no overall survival benefit. In this group of patients, factors such as good response to chemotherapy or limited vascular attachment to less than half circumference or longitudinal 10 mm reduced the risk of local recurrence. Conclusion The proximity of osteosarcoma to major blood vessels is a poor prognostic factor for local control and survival. Amputation offers better local control for tumours attached to the blood vessels but does not improve survival. Limb salvage surgery offers similar local control if the tumour attachment to blood vessels is limited. Cite this article: Bone Joint J 2019;101-B:1024–1031.

Stereotactic Radiosurgical Salvage Treatment for Locally Recurrent Esthesioneuroblastoma

Neurosurgery ◽  
2012 ◽  
Vol 72 (3) ◽  
pp. 332-340 ◽  
Author(s):  
Jamie J. Van Gompel ◽  
Matthew L. Carlson ◽  
Bruce E. Pollock ◽  
Eric J. Moore ◽  
Robert L. Foote ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Local Control ◽  
Additional Patient ◽  
Median Dose ◽  
Single Institution ◽  
Treatment Volume ◽  
Locally Recurrent ◽  
Assess Treatment Response ◽  
Grade 3

Abstract BACKGROUND: Esthesioneuroblastoma (ENB) is a rare malignant neuroendocrine tumor considered to be radiation sensitive. Local recurrence may be treated in a variety of ways, including stereotactic radiosurgery (SRS); however, little information on its effectiveness is available. OBJECTIVE: To determine whether SRS is effective in providing local control for recurrent ENB. METHODS: This was a retrospective single-institution experience including 109 patients with ENB treated at the Mayo Clinic (1962–2009). Sixty-three patients presented with Kadish stage C disease, and 21 patients developed local recurrence. Of these 21 patients, 7 patients underwent SRS at our institution and an additional patient underwent SRS after transnasal biopsy. Therefore, a total of 8 patients are reported. RESULTS: The median age at time of local recurrence was 50 years. All patients had Kadish C disease at initial diagnosis. Six of 8 patients were found to have Hyams grade 3 disease; the remaining 2 patients had grade 2 disease. The median treatment volume was 8.4 cm3 (mean, 18.9 cm3; range, 1.4-76.3 cm3), and the median dose to the tumor margin was 15 Gy (mean, 14.4 ± 2.2 Gy; range, 10-18 Gy). Of the 16 treatments, 13 had adequate follow-up to assess treatment response, with 92% achieving local control over a median follow-up of 42 months from the time of SRS. Five lesions decreased in size, 7 lesions stabilized, and only 1 lesion had in-field progression. There were no documented complications secondary to SRS. CONCLUSION: SRS appears to be a reasonable and safe option for treatment of intracranial recurrence of ENB.

Surgical Therapy of T1 and Selected Cases of T2 Glottic Carcinoma: Cordectomy, Horizontal Glottectomy and CO2 Laser Endoscopic Resection

2000 ◽  
Vol 86 (4) ◽  
pp. 277-282 ◽  
Author(s):  
Roberto Puxeddu ◽  
Federico Argiolas ◽  
Steven Bielamowicz ◽  
Maddalena Satta ◽  
Gian Peppino Ledda ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Co2 Laser ◽  
Local Control ◽  
Salvage Surgery ◽  
Anterior Commissure ◽  
Functional Results ◽  
Cumulative Probability ◽  
Glottic Carcinoma ◽  
Primary Surgery ◽  
Endoscopic Laser

Aims and background Among the different laryngeal neoplasms, glottic carcinoma is known to be one of the most suitable for functional management. Nevertheless, the best treatment for T1 and T2 glottic carcinoma, whether an open neck procedure, endoscopy or radiotherapy, with reference to recurrence, survival, and functional results, has long been debated. Study design From February 1983 to September 1997, 83 patients with well to undifferentiated glottic carcinoma (48 pT1a, 14 pT1b, and 21 selected cases of pT2 with impairment of vocal cord mobility) were submitted to surgery at the Otorhinolaryngologic Section of the Department of Surgical Sciences and Organ Transplantations of Cagliari University. Surgical treatment included 30 laryngofissures with simple or enlarged cordectomy, 22 horizontal glottectomies and 31 endoscopic laser resections. A retrospective review of the records of the patients was performed in order to obtain a better understanding of the outcome of the three different surgical procedures in our institution. Results According to the Kaplan-Meier method, the probability of remaining free of local recurrence 3 years after primary surgery was 0.90 for the T1 group and 0.85 for the T2 group. The distribution of recurrences for cordectomy, glottectomy and CO2 laser at 3 years showed a cumulative probability of remaining free of disease after primary surgery of 0.86, 0.85 and 0.88. The probability of remaining free of local recurrence 3 years after salvage surgery was 0.96 for the T1 group and 0.95 for the T2 group. Analyzing the phenomena for type of surgical procedure, local control at 3 years after salvage surgery for cordectomy, glottectomy and exclusive CO2 laser was 0.93, 0.90 and 0.92, respectively. In the endoscopic group, local control rate after any type of salvage therapy modified the percentage at 3 years to 100%. Anterior commissure spread (AC1-AC2) resulted in a difference (not statistically significant) in local control between the group of patients without and with anterior commissure involvement. Laryngeal preservation was achieved in 93.7% (45/48) of patients who survived after salvage surgery following open neck procedures and in 100% of patients originally submitted to the endoscopic approach. Conclusions In our experience, although open laryngeal procedures can be still considered a valid option in the treatment of T1 and selected cases of T2 glottic carcinoma, endoscopic laser excision offered an oncologically adequate alternative to the traditional techniques, with minimum discomfort for the patient and satisfactory preliminary functional results.

scholarly journals Computed tomography–based image-guided brachytherapy for cervical cancer: correlations between dose–volume parameters and clinical outcomes

2017 ◽  
Vol 59 (1) ◽  
pp. 67-76 ◽  
Author(s):  
Takeaki Kusada ◽  
Takafumi Toita ◽  
Takuro Ariga ◽  
Hitoshi Maemoto ◽  
Seiji Hashimoto ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Patients ◽  
Local Control ◽  
Organs At Risk ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Oncologic Outcomes ◽  
Image Guided ◽  
Future Challenges ◽  
Grade 3

AbstractThis study evaluated the oncologic outcomes and complications of cervical cancer patients in terms of CT-based image-guided brachytherapy (IGBT) parameters. Of 68 cervical cancer patients treated with definitive radiotherapy/concurrent chemoradiotherapy, most received whole-pelvis external beam RT (EBRT) of 40 Gy in 20 fractions, pelvic EBRT with central shield of 10 Gy in 5 fractions, and CT-based IGBT of 18 Gy in 3 fractions prescribed to point A. Cumulative EBRT and IGBT doses were calculated as the total equivalent dose in 2 Gy fractions (EQD2). The median follow-up was 31 (3–52) months. The 2-year overall survival, local control, pelvic control, and disease-free survival rates of the 68 patients were 92%, 83%, 82% and 73%, respectively. The HR-CTV D90, length from the tandem axis to left/right margin of the HR-CTV (T-LR), and HR-CTV volume were significant IGBT parameters for predicting local/pelvic control. Patients who received an HR-CTV D90 of &gt;60 Gy, compared with ≤60 Gy, had significantly better local/pelvic control. Furthermore, 70 Gy was a marginally significant HR-CTV D90 cut-off affecting local control. T-LR was an independent IGBT parameter predicting local/pelvic control on multivariate analysis. Three patients developed Grade 3 or higher treatment-related complications. The D2cm3 of organs at risk were not significant predictors of complications. Future challenges for further improving outcomes include additional interstitial needles for irregularly shaped HR-CTVs, and moderate dose escalation, especially for patients with poor tumor responses.

Definitive radiotherapy for patients with isolated local recurrence of primary resected pancreatic cancer: A retrospective analysis.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 366-366
Author(s):  
Akira Nakamura ◽  
Keiko Shibuya ◽  
Kyoichi Takaori ◽  
Yoshiya Kawaguchi ◽  
Michio Yoshimura ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Local Recurrence ◽  
Local Control ◽  
Local Control Rate ◽  
Definitive Radiotherapy ◽  
Recurrent Pancreatic Cancer ◽  
Locally Recurrent ◽  
Grade 3 ◽  
Isolated Local Recurrence

366 Background: Only surgical resection can provide a chance of long-term survival for patients with pancreatic cancer, but loco-regional recurrence has been a major challenge which inevitably results in poor prognosis and loss of patients’ quality of life. Curative reoperation is seldom attainable but has been suggested to have benefits on overall survival. We hypothesized that definitive radiotherapy could offer a good control for the unresectable local recurrence and improve survival. The primary objective of this retrospective analysis is to evaluate the efficacy and tolerability of definitive radiotherapy for patients with isolated locally-recurrent pancreatic cancer. Methods: A total of 26 patients, who developed local recurrence of primarily resected pancreatic cancer and received radiotherapy between 2000 and 2011, were retrospectively analyzed. The isolated local recurrence was diagnosed with the radiological images (CT/MRI/PET) and tumor marker relapse. The overall survival (OS) and local control rate (LC) were calculated from the start day of radiotherapy and estimated by Kaplan-Meier method. The responses in tumor size and tumor markers were evaluated. The treatment-related toxicity was assessed according to CTC-AE (ver. 4.0). Results: The median total dose of radiotherapy was 50.4 Gy (range, 39.6–54 Gy). Concurrent chemotherapy consisted of gemcitabine (62%), S-1 (19%), and 5-fluorouracil (4%). At a median follow-up time of 13 months, the 1-year OS and median survival were 75% and 21.6 months, respectively. The 1-year local control rate was 59%. Objective radiological response was not seen. The tumor marker reduction and ≥ 50% reduction were observed in 65% and 12%. Grade≥3 hematological toxicity was seen in 62%. Grade ≥ 3 of acute gastrointestinal toxicity was not observed. At a late phase, Grade 3 ileus observed in one, and Grade 3 gastric bleeding ulcer was seen in one patient. Conclusions: Definitive radiotherapy resulted in encouraging local control and overall survival for patients with isolated locally-recurrent pancreatic cancer. This treatment strategy should be further evaluated prospectively.

Outcomes and toxicity for hypofractionated and single-fraction image-guided stereotactic radiosurgery for sarcoma metastatic to the spine.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9501-9501
Author(s):  
Michael Ryan Folkert ◽  
Mark Bilsky ◽  
Ashlyn K. Tom ◽  
Kaled M. Alektiar ◽  
Ilya Laufer ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Local Control ◽  
Cox Regression ◽  
Radiation Treatment ◽  
Effective Means ◽  
Radiation Sensitivity ◽  
Median Dose ◽  
Single Fraction ◽  
Image Guided ◽  
Grade 3

9501 Background: Conventional radiation treatment (20-40 Gy total dose, 5-20 fractions, 2-5 Gy per fraction) for sarcoma metastatic to the spine provides subtherapeutic doses and results in poor local control (58-77% at 1 year). Hypofractionated (HF) and/or single-fraction (SF) image-guided stereotactic radiosurgery (IG-SRS) may provide a more effective means of control and salvage for these lesions. Methods: Patients with pathologically-proven high-grade sarcoma metastatic to the spine treated with HF and SF IG-SRS were included. Local control (LC) and overall survival (OS) were analyzed using Kaplan-Meier statistics; univariate/multivariate analyses were performed using Cox regression. Toxicities were assessed according to CTCAE v4.0 criteria. Results: From 5/2005 and 11/2012, 88 patients with 120 discrete metastases were treated with HF (3-6 fractions, median dose 28.5 Gy; n=52, 43.3%) or SF IG-SRS (median dose 24 Gy, n=68, 56.7%). Median followup was 12.3 months. LC at 12 months was 87.9% (95% CI 81.3-94.5%). OS at 12 months was 60.6% (95% CI 49.6-71.6%) with a median survival of 16.9 months. SF IG-SRS demonstrated superior LC to HF IG-SRS (P=.007) (Table). SF IG-SRS retained its significance in terms of improved LC on multivariate analysis, HR 0.304 (95% CI: 0.117-0.790); variables tested included prior radiation therapy, histology, IG-SRS fractionation, surgery, and chemotherapy. Treatment was well-tolerated with 1% acute Grade 3 toxicity and 4.5% chronic Grade 3 toxicity observed; there were no > Grade 3 toxicities. Conclusions: In the largest series of metastatic sarcoma to the spine to date, image-guided stereotactic radiosurgery provides excellent local control in the setting of an aggressive disease with low radiation sensitivity and poor prognosis. Single-fraction image-guided stereotactic radiosurgery demonstrates the highest rates of local control with minimal toxicity. [Table: see text]

Five-year results for image-guided brachytherapy (IGBT) for cervical carcinoma: a report from single institute of Thailand

2016 ◽  
Vol 16 (1) ◽  
pp. 38-45
Author(s):  
Ekkasit Tharavichitkul ◽  
Somvilai Chakrabandhu ◽  
Pitchayaponne Klunklin ◽  
Wimrak Onchan ◽  
Bongkot Jia-Mahasap ◽  
...  
Keyword(s):  
Cervical Carcinoma ◽  
Local Control ◽  
Clinical Target Volume ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Target Volume ◽  
Long Term Results ◽  
Image Guided ◽  
Grade 3

AbstractAimTo report of long-term results and toxicity profiles using image-guided brachytherapy (IGBT) combined with whole pelvic radiation therapy (WPRT) for cervical carcinoma.Materials and MethodsIn total, 52 patients with locally advanced cervical carcinoma were enrolled into the study. WPRT was used to treat the clinical target volume (CTV) with a dose of 45–50·4 Gy in 23–28 fractions. IGBT using computed tomography was performed at the dose of 6·5–7 Gy×4 fractions to the minimum dose covering 90% of target volume (D90) of high-risk clinical target volume (HR-CTV).ResultsThe mean cumulative dose in equivalent doses of 2 Gy for the D90 of HR-CTV, dose at 2% at refereed volume (D2cc) of bladder, D2cc of rectum and D2cc of sigmoid colon were 92·4, 87·9, 69·6, and 72 Gy, respectively. At the median follow-up time of 61 months, the 5-year local control, disease-free survival, and overall survival rates were 96·2, 75 and 84·6% respectively. Two patients (3·8%) developed grade 3–4 gastrointestinal and two patients (3·8%) developed grade 3–4 genitourinal toxicities.ConclusionThe combination of WPRT plus IGBT showed very promising long-term results with excellent local control and toxicity profiles.

Salvage surgery for local recurrence after breast conservation therapy—Is re-lumpectomy an appropriate treatment?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 608-608
Author(s):  
T. Ofuchi ◽  
A. Amemiya ◽  
M. Ono ◽  
J. Hatayama ◽  
A. Takeda
Keyword(s):  
Local Recurrence ◽  
Local Control ◽  
Systemic Therapy ◽  
Salvage Surgery ◽  
Clinical Stage ◽  
Breast Conservation ◽  
Local Therapy ◽  
Stage I ◽  
Immediate Reconstruction

608 Background: Since 1983 through 2005, 2439 clinical stage I or II patients (pts) were treated with lumpectomy and postoperative irradiation. During median follow-up of 75 months, 142 patients experienced local recurrence as first and sole event were judged as candidate for further local therapy. The purpose of this study is to evaluate the outcome of salvage treatment, with specific reference to feasibility of second breast conservation surgery. Methods: Among those with operable local recurrences, 73 pts who requested conservation of their breasts and whose recurrences were judged to be small enough to be locally re-excised with adequate margins underwent second lumpectomy (Re-LMP). 51 pts were treated by mastectomy with or without immediate reconstruction (MAS). Adjuvant systemic therapy of limited duration was given at the discretion of patients and therapists. Survival and local re-recurrence after salvage surgery were estimated by Kaplan-Meier method. Results: Age of patients ranged from 28–69 (mean: 41). Median follow-up length after salvage surgery was 53 months (6–194 months). Patient/Tumor characteristics were similar in Re-LMP and MAS groups. Local re-recurrence: Re-LMP: 31 pts developed in-breast re-recurrence (34% at 3yrs, 49% at 5yrs). MAS: 6 pts experienced chest wall recurrence (11% at 3yrs, 11% at 5yrs, p=0.0005). Independent risk factor for re-recurrence was not identified. Survival: In initial clinical stage I patients, 3 pts treated with Re-LMP died after salvage surgery and all treated with MAS survived (94% and 100% at 5yrs, p=0.2). In clinical stage II patients, 6 in Re-LMP and 8 patients in MAS died (89%, 57% at 5yrs after salvage surgery, p=0.02). Poor prognostic factors for both groups were initial stage and stage at the time of local failure. Conclusions: For an isolated in-breast recurrence, salvage mastectomy with or without immediate reconstruction provides excellent local control. At the present time, mastectomy should be offered as 1st treatment option. Although survival is not jeopardized, Re-LMP alone does not offer adequate local control. Additional local therapy i.e. re-radiotherapy or aggressive systemic therapy may improve this poor result. Prospective studies should be initiated. No significant financial relationships to disclose.

Delivering a third course of radiation to spine metastases using image-guided, intensity-modulated radiation therapy

2013 ◽  
Vol 18 (1) ◽  
pp. 63-68 ◽  
Author(s):  
Evangelia Katsoulakis ◽  
Nadeem Riaz ◽  
Brett Cox ◽  
James Mechalakos ◽  
Joan Zatcky ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Radiation Therapy ◽  
Median Time ◽  
Local Control ◽  
Cauda Equina ◽  
Intensity Modulated Radiation Therapy ◽  
Image Guided ◽  
Intensity Modulated ◽  
Grade 3

Object The objective of this study was to investigate the feasibility and safety of delivering a third course of radiation to patients with multiply recurrent metastatic disease to the spine. Methods Between 2009 and 2011, 10 patients received a third course of radiation to spinal metastases at Memorial Sloan–Kettering Cancer Center using image-guided intensity-modulated radiation therapy (IMRT). Patient and tumor characteristics, dosimetry details, and outcomes were obtained using retrospective chart review. Spinal imaging was performed prior to treatment and at regular follow-up intervals. The cumulative biologically effective dose (BED) to the spinal cord and cauda equina was calculated and was normalized to 2 Gy equivalents (Gy2/2). Toxicity and local control were assessed. Results The median time between the first and second courses of radiation was 18.5 months and the median time between the second and third courses was 11.5 months. The median follow-up from the third course of radiation was 12 months and the median overall survival was 13 months. Pain or neurological symptoms were improved in 80% of patients. The median spinal cord maximum dose normalized BED (nBED) for the whole cohort was 70.73 Gy2/2 (range 51.9–101.7 Gy2/2). The median dose to 5% of the spinal cord D05 nBED for the entire cohort was 59.4 Gy2/2. Acute toxicity was most commonly fatigue and dermatitis, with 1 patient experiencing Grade 3 fatigue and 1 patient Grade 3 dermatitis. Late toxicity was limited to 2 cases of Grade 1 dysphagia. There was 1 case of Grade 1 neuropathy and 1 case of Grade 2 neuropathy. The crude rate of local control was 80% with 1 in-field failure and 1 marginal failure. Conclusions In this cohort of patients, a third course of IMRT to the spine was well tolerated with no significant late toxicities. Used as salvage therapy for select patients, a third course of radiation is a safe and effective treatment strategy.

Phase II Study of Oxaliplatin, Fluorouracil, and Folinic Acid in Locally Advanced or Metastatic Gastric Cancer Patients

2002 ◽  
Vol 20 (23) ◽  
pp. 4543-4548 ◽  
Author(s):  
C. Louvet ◽  
T. André ◽  
J.M. Tigaud ◽  
E. Gamelin ◽  
J.Y. Douillard ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Folinic Acid ◽  
Performance Status ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Curative Intent ◽  
Suitable Alternative ◽  
Best Response ◽  
Grade 3 ◽  
Gastric Cancer Patients

PURPOSE: To evaluate the efficacy and safety of an oxaliplatin, fluorouracil (5-FU), and folinic acid (FA) combination in patients with metastatic or advanced gastric cancer (M/AGC). PATIENTS AND METHODS: Of the 54 eligible patients with measurable or assessable M/AGC, 53 received oxaliplatin 100 mg/m2 and FA 400 mg/m2 (2-hour intravenous infusion) followed by 5-FU bolus 400 mg/m2 (10-minute infusion) and then 5-FU 3,000 mg/m2 (46-hour continuous infusion) every 14 days. RESULTS: Patients (69% male, 31% female) had a median age of 61 years (range, 31 to 75 years), 89% had a performance status of 0 or 1, 70% had newly diagnosed disease, and 87% had metastatic disease. All had histologically confirmed adenocarcinoma. With a median of three involved organs, disease sites included the lymph nodes (67%), stomach (65%), and liver (61%). A median of 10 cycles per patient and 468 complete cycles were administered. Best responses in the 49 assessable patients were two complete responses and 20 partial responses, giving an overall best response rate of 44.9%. Eight patients underwent complementary treatment with curative intent (six with surgery and two with chemoradiotherapy). Median follow-up, time to progression, and overall survival were 18.6 months, 6.2 months, and 8.6 months, respectively. Grade 3/4 neutropenia, leukopenia, thrombocytopenia, and anemia occurred in 38%, 19%, 4%, and 11% of patients, respectively, and febrile neutropenia occurred in six patients (one episode each). Grade 3 peripheral neuropathy occurred in 21% of patients (oxaliplatin-specific scale). Seven patients withdrew because of treatment-related toxicity. CONCLUSION: This oxaliplatin/5-FU/FA regimen shows good efficacy and an acceptable safety profile in M/AGC patients, and may prove to be a suitable alternative regimen in this indication.

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