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Biomedical subjects

F A Calvo

Publications and source records attributed to F A Calvo.

At least 19 recordsLinked to original sources
PubMed2006

Improved incidence of pT0 downstaged surgical specimens in locally advanced rectal cancer (LARC) treated with induction oxaliplatin plus 5-fluorouracil and preoperative chemoradiation.

PURPOSE: To compare efficacy in terms of pathologic response in LARC patients treated with preoperative chemoradiation, with or without a short-intense course of induction oxaliplatin. PATIENTS AND METHODS: From 05/98 to 10/02, 114 patients were treated with preoperative chemoradiation (4500-5040 cGy + oral Tegafur 1200 mg/day) for cT(3)-(4)N(+/x)M(0) rectal cancer. Starting 05/01, 52 consecutive patients additionally received induction FOLFOX-4, oxaliplatin (85 mg/m(2) iv d1), 5-FU (400 mg/m(2) iv bolus d1) and 600 mg/m(2) iv continuous infusion in 22 h with leucovorin (200 mg iv) d1 and d2, every 15 days (2 cycles), followed by the previously described Tegafur chemoradiation regime. Surgery was performed in 5-6 weeks. Pathological assessment investigated post-treatment T and N status in the rectal wall and peri-rectal tissues. RESULTS: Patients, tumor and treatment characteristics were comparable between groups. Incidence of pT(0) specimens was significantly increased by induction FOLFOX-4 (P = 0.006). Total T and N downstaging were 58% versus 75% and 42% versus 40%, respectively (P = ns). T downstaging of > or =2 categories was significantly superior in FOLFOX-4 group (P = 0.029). CONCLUSIONS: Short-intense induction FOLFOX-4 significantly improves pathologic complete response in LARC patients treated with tegafur-sensitized preoperative chemoradiation. The 44% rate of pT(0)-(1) specimens observed in the oxaliplatin group should impulse innovative surgical approaches to promote ano-rectal sphincter conserving protocols.

Adult↗
PubMed2006

Tegafur and 5-fluorouracil pelvic tissue concentrations in rectal cancer patients receiving preoperative chemoradiation.

BACKGROUND AND PURPOSE: To investigate the presence of 5-Fluorouracil (5-FU) in pelvic tissue after oral administration of tegafur. To measure tegafur and 5-FU concentrations in normal rectal mucosa, perirectal fat and residual tumor in rectal cancer patients receiving preoperative chemoradiation. To correlate drug concentrations with cancer downstaging effects. PATIENTS AND METHODS: Three tissue samples taken from 16 surgical specimens after recto-sigmoid resection were analyzed. Tegafur and 5-FU concentrations were measured using high-performance liquid chromatography. 16 patients with locally advanced rectal cancer were treated with preoperative pelvic irradiation (45-50 Gy) sensitized with oral tegafur (400 mg for every 8 hours daily). Seven patients received a precharge dose of tegafur (400 mg oral every 8 hours) 24 hours before surgery. RESULTS: In 8 of the 9 patients who did not receive a precharge dose, detectable levels of tegafur were observed in fat tissue, normal mucosa and tumor, but detectable 5-FU levels were only observed in one patient. Mean concentrations (ranges) for tegafur in fat, normal mucosa and tumor in patients without the precharge dose were 72.19 (12.1-205.6), 179.53 (11.30-727.7) and 252.35 (27.9-874.6) ng/g, respectively; mean concentrations for 5-FU in the same samples were 0.95, 1.92 and 2.68 ng/g (1 patient), respectively. In patients receiving a tegafur precharge, both tegafur and 5-FU were present in all tissue samples with the exception of 2 fat samples, in which drug concentrations were undetectable. 5-FU levels were higher in tumor than other sites, with a median value of 68.24 ng/g (range 3.8-283.05 ng/g). Tegafur levels were also higher in tumor samples than other sites (mean 3446.53 ng/g, range 1044.5-7847.0 ng/g), except in 2 patients who had higher levels of tegafur in normal mucosa. CONCLUSIONS: Tegafur and 5-FU are not always present in pelvic tissues 5 to 6 weeks after oral administration of tegafur. Both drugs were present in the tissues analyzed, in relevant concentrations, 24 hours after oral administration of tegafur. The data obtained suggest a tendency (not significant) toward a correlation between levels of 5-FU present in the residual tumor and cancer downstaging.

Adipose Tissue↗
PubMed2001

Pathologic downstaging of T3-4Nx rectal cancer after chemoradiation: 5-fluorouracil vs. Tegafur.

PURPOSE: To describe downstaging effects in locally advanced rectal cancer induced by 2 fluopirimidine radiosensitizing agents given through different routes in conjunction with preoperative radiotherapy. METHODS AND MATERIALS: From March 1995 to December 1999, two consecutive groups of patients with cT3-4Nx rectal cancer (94% CT scan, 71% endorectal ultrasound) were treated with either (1) 45-50 Gy (1.8 Gy/day, 25 fractions) and 5-fluorouracil (5-FU) (500-1,000 mg/m2 by 24-h continuous i.v. infusion on Days 1-4 and 21-25) or (2) oral Tegafur (1,200 mg/day on Days 1-35, including weekends). Surgery was performed 4 to 6 weeks after the completion of chemoradiation. RESULTS: The total T downstaging rate was 46% in the 5-FU group and 53% in the Tegafur group. Subcategories were downstaged by the sensitizing agents (5-FU vs. Tegafur) as follows: pT0-1, 14% vs. 23%; pT2, 32% vs. 32%; pT3, 49% vs. 37%; pT4, 5% vs. 7%; and N(0), 74% vs. 86%. Analysis of residual malignant disease in the specimen discriminated mic/mac subgroups (mic: <20% of microscopic cancer residue), with evident superior downstaging effects in the Tegafur-treated group: pTmic 23% vs. 58% (p = 0.002). CONCLUSIONS: When administered concurrent with pelvic irradiation, oral Tegafur induced downstaging rates in both T and N categories superior to those induced by intermediate doses of 5-FU by continuous i.v. infusion. In this pilot experience, oral Tegafur reproduced the characteristics of downstaging described previously when full doses of 5-FU have been combined with radiotherapy.

Adult↗
PubMed2001

Long-term normal tissue effects of intraoperative electron radiation therapy (IOERT): late sequelae, tumor recurrence, and second malignancies.

PURPOSE: To evaluate long-term survivors treated with intraoperative electron radiation therapy (IOERT) as a component, with particular emphasis on analyzing late normal tissue toxicity, second malignancies, and patterns of delayed tumor recurrence. METHODS AND MATERIALS: From September 1984 to December 1991, 739 patients were treated with IOERT. One hundred ninety-five patients were alive at least 5 years after IOERT (26%). Patient information regarding late complications related symptoms, incidence of second tumors, and delayed relapses were analyzed. Normal tissue changes were categorized by a modified LENT/SOMA scale (Grade 0-1, Grade 2, and Grade 3-4). Risk of late toxicity was grouped by type and number of cancer treatment modalities employed in each patient: surgery + IOERT alone (17 patients, 9%); IOERT + external radiotherapy +/- chemosensibilization (90 patients, 46%); IOERT +/- external radiotherapy +/- neoadjuvant chemotherapy (+/- previous radiotherapy) (88 patients, 45%). Biologic effective doses (BED) were calculated for alpha/beta = 3.5 for late fibrosis. RESULTS: With a mean follow-up time of the surviving patients of 94 months (range: 55-162 months), 99 patients (51%) had Grade 0-1 toxicity, 52 (27%) had Grade 2, and 44 patients (23%) presented Grade 3-4 late normal tissue complications. Risk groups by treatment intensity did correlate with severity of observed toxicity (p < 0.001). BED estimations did not correlate with late normal tissue damage. The tumor type with higher toxicity scores was bone sarcoma (28/46, 60%), in which the estimated BED = 100.5 Gy. Peripheral neuropathy was the dominant IOERT-specific toxicity present in 24 patients (12%). Second malignancies were identified in 8 patients (4%), none inside the IOERT field (3 questionable to be marginal to the external beam radiotherapy volume). In 36 patients (18%), recurrence of the originally treated tumor was detected, including 11 (7%) local relapses. CONCLUSIONS: The incidence of late normal tissue complications (50%) and severity (23%) is significant in a cohort of patients surviving more the 5 years after IOERT. The understanding of the contribution of IOERT to late tissue damage requires specific analysis. Peripheral neuropathy is a characteristic finding in IOERT trials. Second malignancies inside the IOERT field were not identified during the study period. The risk of recurrences, including local failures, requires an intensive follow-up of long-term survivors from IOERT trials.

Combined Modality Therapy↗
PubMed1999

Self-administered joint counts in rheumatoid arthritis: comparison with standard joint counts.

OBJECTIVE: To test the reliability and validity of a self-administered 36 joint count developed after the Rapid Assessment of Disease Activity in Rheumatology (RADAR) questionnaire for assessing pain/tenderness. METHODS: Two self-administered formats (mannequin and text) were evaluated in 60 patients with rheumatoid arthritis (RA). Reliability between both formats was tested by Spearman rank correlation. Criterion validity/accuracy was tested by Spearman correlation coefficient between each self-report format and a joint count performed by a physician. Construct validity was ascertained by correlation of each format with other variables of disease activity. RESULTS: Reliability between the 2 formats was high (R = 0.94). Correlations between each format and the physician's joint count were also high (R = 0.77 for mannequin, 0.75 for text). Patients consistently rated their joint pain/tenderness higher than the physician (means 29, 27, and 12 for text, mannequin, and physician, respectively; p < 0.01). Construct validity of the text, mannequin, and physician formats compared with the modified Health Assessment Questionnaire showed R = 0.61, 0.65, 0.63; with Steinbrocker functional class R = 0.41, 0.46, 0.56; with pain R = 0.59, 0.61, 0.62; with global evaluation R = 0.66, 0.71, 0.84; and with morning stiffness R = 0.64, 0.59, 0.60, respectively. CONCLUSION: Although both self-administered formats exhibited adequate reliability and construct validity, a systematic difference between patient and physician/trained assistant performed joint counts was observed, with patients consistently rating their pain/tenderness higher. We thus do not believe they can replace standard physician/trained assistant evaluation in obtaining clinical research data in rheumatology.

Acute Disease↗
PubMed1997

Patterns of failure and long-term results in high-risk resected gastric cancer treated with postoperative radiotherapy with or without intraoperative electron boost.

BACKGROUND: To evaluate the possible role of adjuvant radiotherapy in the management of high-risk resected gastric carcinoma. METHODS: From 1982 to 1993, 62 patients surgically resected of a primary gastric cancer with adverse pathological features (serosal and/or regional lymph node involvement) were treated with postoperative radiotherapy with (Group I) or without (Group II) intraoperative electron boost to the surgical bed and coeliac axis (IORT). RESULTS: After a median follow-up of 75.6 months (range 4-120+) for IORT patients and 91.2 months (range 6-149+) for non-IORT patients, overall relapse rates for Group I and Group II patients were 44.5% and 48.6% and local-regional relapse rates were 11.1% and 20%, respectively. Actuarial survival rates projected at the maximum follow-up were 41% and 38% in Groups I and II, respectively. CONCLUSIONS: This retrospective analysis suggests a beneficial effect of adjuvant external radiotherapy in promoting local-regional control in high-risk resected gastric cancer.

Adult↗
PubMed1997

Simulated surgery on computed tomography and magnetic resonance images: an aid for intraoperative radiotherapy.

Intraoperative radiotherapy (IORT) is a relatively new technique in which irradiation with electrons is performed during an open surgery procedure. This approach poses significant problems in obtaining accurate dosimetry, since neither the pre- nor the postoperative patient images actually matches the irradiation field. Our objective was to implement a software tool able to provide an estimate of the dose distribution, overcoming the problem of the geometrical mismatch between the images and the surgical field during the irradiation. The program was developed in the C programming language, on a noncommercial version of a Philips EasyVision workstation. The application allows to create a new data set by manipulating the preoperative computed tomography and magnetic resonance images in order to simulate the final geometry of the surgical area during the IORT procedure. The exact dose distribution can then be calculated by transferring these new images to a standard radiotherapy planning system. Also an approximate dose distribution can be quickly displayed by superimposing isodose curves obtained from a water phantom. The proposed approach introduces a helpful tool for dosimetry and planning in IORT protocols, improving their accuracy and safety and allowing for more objective quality control and patient follow-up.

Brain Neoplasms↗
PubMed1995

Intraoperative radiation therapy in malignant glioma: early clinical results.

Intraoperative radiation therapy (IORT) with high energy electron beams is a treatment modality that has been included in multimodal programs in oncology to improve local tumor control. From August 1991 to December 1993, 17 patients with primary (8) or recurrent (9) high grade malignant gliomas, anaplastic astrocytoma (4), anaplastic oligodendroglioma (6) and glioblastoma multiforme (7), underwent surgical resection and a single dose of 10-20 Gy intraoperative radiation therapy was delivered in tumor bed. Fourteen patients received either pre-operative (8) or post-operative (6) external beam radiation therapy. Primary gliomas: 18-months actuarial survival rate has been 56% (range: 1-21+ months) and the median survival time has not yet been achieved. Four patients developed tumor progression (median time to tumor progression: 9 months). Recurrent gliomas: 18-months actuarial survival rate and median survival time has been 47% and 13 months (range: 6-32+ months) respectively. The median time to tumor progression was 11 months. No IORT related mortality has been observed. IORT is an attractive, tolerable and feasible treatment modality as antitumoral intensification procedure in high grade malignant gliomas.

Adolescent↗
PubMed1993

Intraoperative radiotherapy in locally advanced recurrent colorectal cancer.

PURPOSE: In an effort to promote local control and improve quality of life in patients with recurrent colorectal cancer, a multimodality approach has been used. METHODS AND MATERIALS: Twenty-seven patients were treated with moderate doses of pre/postoperative radiotherapy with/without simultaneous systemic chemotherapy, surgical re-resection and IORT electron boost over areas at high risk for local recurrence. RESULTS: The 2-year actuarial disease-free and local relapse-free survival for the entire group were 14% and 26%, respectively. The most important factor predicting a favorable outcome was the radicality of surgical procedure. The determinate local control rate and the actuarial 2-year local relapse-free, and disease-free survival for patients undergoing complete resections were 50%, 56%, and 34%, respectively, whereas for patients undergoing partial resections these figures were 16%, 13%, and 6%. The radicality of surgical procedure was influenced by both tumoral size and previous treatment with irradiation. Complete resection rate was higher in patients with tumors less than 5 cm vs. more than 5 cm (40% vs. 22%), and in patients without previous radiotherapy versus those with previous radiotherapy (40% vs. 28%). Distant metastasis rate was high (41%). The most significant toxicities attributable to the whole treatment protocol were enteritis (37%), hydronephrosis (30%), and pelvic neuropathy (52%). CONCLUSION: Currently, our policy is to recommend IORT in patients with "favorable factors" such as: absence of previous pelvic radiotherapy, single previous surgical procedure, and complete resections.

Adult↗
PubMed1993

New advances in radiation oncology for gynecologic cancer.

In 1992, the American Cancer Society anticipates that there will be 1,130,000 new cases of invasive cancer diagnosed in the United States. About 66,500 will be invasive cancers of the cervix, uterus, and ovary. About 22,400 patients will die during 1992, with 50-60% of those deaths being due to persistent local regional disease. Data are available to suggest that a reduction in local failure will be reflected by an increase in survival free of disease. In 1992, major efforts are being made to reduce the incidence of local failure. Three areas in this regard are innovative uses of brachytherapy, intraarterial chemotherapy and radiation therapy, and continuous infusion chemotherapy and radiation therapy. These new techniques show significant reduction in local failure with associated improvement in survival. The data will be presented to illustrate the impact of these techniques.

Antineoplastic Agents↗
PubMed1993

Intraoperative radiotherapy in recurrent gynecological cancer.

A retrospective analysis to assess the feasibility and clinical tolerance of intraoperative radiotherapy (IORT) in the treatment of recurrent gynecologic cancer is reported. From February 1985 to September 1992, 26 patients with recurrent gynecologic tumors entered this trial. The clinical experience comprises two different categories of disease situations: tumors relapsing after full dose radiation therapy (group I) and recurrent disease to previous surgery (group II). Cervical carcinoma was the initial tumor site of involvement in 18 patients (69%). Treatment consisted in maximal surgical resection + IORT boost (10-25 Gy) to the high-risk areas for recurrence. Non previously irradiated patients also received external beam irradiation (EBRT) (+/- chemotherapy) pre- or postoperatively. IORT-related toxicity was one episode of motor neuropathy. Local control rates have been 33% and 77%, respectively in groups I and II. The 4-year actuarial overall survival in Group I is 7% and 6-year actuarial overall survival in Group II is 33%. The addition of IORT to surgical debulking achieves modest local control and long-term survival rates if tumor-free margins cannot be obtained in previously irradiated patients. Combined EBRT (+/- chemotherapy) maximal surgical resection plus IORT could render some long-term survivors among those surgical recurrent patients not candidates for radical surgery with curative intent.

Adolescent↗