levoleucovorin and Anus-Neoplasms

The majority of colorectal neoplasms diagnosed are adenocarcinomas. Other histologies such as squamous, adenosquamous, carcinoid tumors, or lymphoid tumors are occasionally identified. Given the rarity of squamous-cell tumors, it is very difficult to study their natural course and response to therapy. An attempt is made to describe the frequency, anatomic location, and response to therapy with a review of the literature.. From the Cancer Registry at the University of Missouri-Columbia Ellis Fischel Cancer Center, tumors of the colon identified above the dentate line were selected for chart review. Data were extracted from cases between the years 1940 and 1996. The key terms used to identify cases were epidermoid, squamous cell, and cancer of the rectum or colon. Using this approach, forty patients were identified and each record was reviewed.. The majority of these cases were anal cancers with proximal extension into the rectum and were excluded. Of 4,561 cases of epithelial colon and rectal cancers identified, only one additional case of squamous-cell cancer could be verified. In this report we describe a patient with a primary squamous-cell carcinoma of the sigmoid colon with metastatic disease to the liver at diagnosis who responded to systemic chemotherapy. We believe this to be the first reported case of this rare tumor type in which the patient's tumor responded to systemic chemotherapy. Two cases with a thorough review of literature are presented.. Primary squamous-cell carcinoma of the colon is a rare malignancy of unknown cause and pathogenesis. Metastatic tumors to the colon should be ruled out in all cases before therapy. Early detection and surgery remain the main therapeutic options, but as presented in our case, response to chemotherapy in advanced disease is encouraging.

Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carcinoma, Squamous Cell; Cisplatin; Colonic Neoplasms; Female; Fluorouracil; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Leucovorin; Male; Middle Aged; Rectal Neoplasms

Although squamous cell anal carcinomas are relatively rare, their incidence has been increasing steadily. Because of the limited data, treatment of metastatic disease is a major therapeutic challenge. In this study, we report the safety and efficacy of epidermal growth factor receptor (EGFR) inhibitors in patients with advanced squamous cell anal carcinomas.. A retrospective analysis was conducted using the Moffitt Cancer Tumor Registry from January 2009 to January 2014. Eligible patients had diagnosis of advanced squamous cell anal carcinomas and received an EGFR inhibitor as part of their treatment.. A total of 13 patients were identified for analysis. All of them received concurrent chemoradiation as initial treatment and subsequently had recurrence. Five patients received single agent cetuximab or panitumumab, and the others received cetuximab or panitumumab with irinotecan or FOLFIRI. The objective response rate was 30.8% including 1 complete response, and the disease control rate was 46.2%. With a median follow-up of 9.6 months, the median progression-free survival and median overall survival were 4.4 months and 11.4 months, respectively.. Our analysis suggests that EGFR inhibitors have potential efficacy and are reasonably well tolerated in patients with squamous cell anal carcinomas. These findings warrant further evaluation in a large prospective trial.

Topics: Adult; Aged; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Camptothecin; Carcinoma, Squamous Cell; Cetuximab; Chemoradiotherapy; ErbB Receptors; Female; Florida; Fluorouracil; Humans; Irinotecan; Leucovorin; Male; Middle Aged; Neoplasm Recurrence, Local; Panitumumab; Protein Kinase Inhibitors; Retrospective Studies; Treatment Outcome

This trial evaluated the efficacy and safety of CT guided (125)I-seed implantation (CTII) plus chemotherapy with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment for locally recurrent rectal cancer (LRRC).. Patients with LRRC who received one prior chemotherapy regimen were enrolled and divided randomly assigned to FOLFORI alone (Arm A) and FOLFORI plus CTII (Arm B). The primary endpoint was local control time (LCT). Overall survival (OS) and treatment related adverse events (TRAEs) were also observed.. Fifty-seven patients were enrolled from October 2008 and December 2014. Twenty-seven were assigned into Arm A and 30 into Arm B. The overall response rate of locally recurrent tumor was improved to 100% in Arm B versus 29.6% in Arm A (P<0.001). A significant longer LCT was observed in Arm A (P<0.001); median LCT was 12 months in Arm B versus 4 months in Arm A. A borderline significant improvement in OS was also observed in Arm B (P=0.0464); median OS was 25 months in Arm B versus 19 months in Arm A. For patients without distant metastases, median OS was 37 months in Arm B versus 21 months in Arm A (P=0.0101). For patients with (neo)adjuvant radiotherapy (ART), a longer LCT and OS were also found in Arm B (P<0.001 and P=0.0217, respectively). TRAEs were not serious generally. There was no statistically significant difference in treatment related toxicity between Arm A and B both for all patients and patients receiving ART.. CTII plus FOLFIRI improves the LCT with tolerable toxicities as a second-line treatment in patients with local recurrent rectal cancer, and is helpful to prolong the OS, particularly in patients without distant metastases or with a history of radiotherapy.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Brachytherapy; Camptothecin; Combined Modality Therapy; Female; Fluorouracil; Humans; Iodine Radioisotopes; Leucovorin; Male; Middle Aged; Neoplasm Recurrence, Local; Radiotherapy, Image-Guided; Survival Analysis; Tomography, X-Ray Computed; Treatment Outcome; Young Adult

To determine the dosimetric parameters predictive of acute gastrointestinal (GI) toxicity in anal cancer patients treated with intensity-modulated radiotherapy (IMRT) and concurrent chemotherapy.. Fifty-eight anal cancer patients were treated with concurrent chemotherapy and IMRT. The bowel was delineated on the planning CT and included the intestinal cavity. Regression models with multiple independent predictors were used to test associations of clinical factors and dosimetric parameters with clinically significant GI toxicity (grade ≥3). Significant dosimetric factors were fitted to a normal tissue complication probability curve using a logit function and subsequently analyzed at multiple bowel volumes to determine the threshold for clinically significant GI toxicity.. Two patients (3.4%) experienced no acute GI toxicity, whereas 20 (34.5%) experienced grade 1 toxicity, 20 (34.5%) experienced grade 2, 16 (27.6%) experienced grade 3 and none experienced grade 4. Analysis showed that the volumes of bowel receiving 30 Gy (V30) and 40 Gy (V40) both correlated with clinically significant acute GI toxicity. In patients whose V30 was >310 cm(3), the rate of clinically significant acute GI toxicity was 38.9%, compared to 9.1% if V30 was ≤310 cm(3) (p = 0.016). If V40 was ≤70 cm(3), the rate of acute grade ≥3 toxicity was 6.3%, versus 35.7% if V40 was >70 cm(3) (p = 0.045).. This analysis demonstrates that the bowel dosimetric parameters are associated with clinically significant acute GI toxicity when IMRT is used in the management of anal cancer patients.

Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Chemoradiotherapy; Cisplatin; Female; Fluorouracil; Gastrointestinal Tract; Humans; Leucovorin; Male; Middle Aged; Radiation Injuries; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Radiotherapy, Intensity-Modulated; Regression Analysis

In order to investigate the medical treatment of anal canal carcinoma (ACC), 27 patients (pts) were treated with cisplatin, fluorouracil and radiotherapy, in an alternating schedule. Eleven pts received mitomycin C, fluorouracil and radiotherapy, in a concurrent scheme. Finally, six pts were included in a new outpatient scheme with cisplatin, fluorouracil, leucovorin, mitomycin C and concurrent radiotherapy. Within the first schedule, 25 pts were evaluable and 18 achieved complete response. All of them are disease free until now. With the second scheme, 7/10 pts had a complete response and 5 of them are alive and disease free. All the pts included in the last schedule (6/6) achieved complete remission. There were no deaths related to toxicity. Our experience is one of the earliest in oncology using cisplatin as a first line drug, in the non-surgical treatment of ACC. We think that the use of cisplatin is feasible, its toxicity is manageable, and its effectivity is similar to other schedules, as observed in our last scheme.

Topics: Adult; Aged; Antibiotics, Antineoplastic; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carcinoma, Squamous Cell; Cisplatin; Clinical Protocols; Female; Fluorouracil; Follow-Up Studies; Humans; Leucovorin; Male; Middle Aged; Mitomycin; Time Factors

Treatment of advanced anal squamous cell cancer (SCC) is usually with the combination of cisplatin and 5-fluorouracil, which is associated with heterogeneous responses across patients and significant toxicity. We examined the safety and efficacy of a modified schedule, FOLFCIS (leucovorin, fluorouracil, and cisplatin), and performed an integrated clinical and genomic analysis of anal SCC.. We reviewed all patients with advanced anal SCC receiving first-line FOLFCIS chemotherapy - essentially a FOLFOX (leucovorin, fluorouracil, and oxaliplatin) schedule with cisplatin substituted for oxaliplatin - in our institution between 2007 and 2017, and performed deep sequencing to identify genomic markers of response and key genomic drivers.. Fifty-three patients with advanced anal SCC (48 metastatic; 5 unresectable, locally advanced) received first-line FOLFCIS during this period; all were platinum-naive. The response rate was 48% (95% confidence interval [CI], 32.6%-63%). With a median follow-up of 41.6 months, progression-free survival and overall survival were 7.1 months (95% CI, 4.4-8.6 months) and 22.1 months (95% CI, 16.9-28.1 months), respectively. Among all patients with advanced anal SCC that underwent sequencing during the study period, the most frequent genomic alterations consisted of chromosome 3q amplification (51%) and mutations in PIK3CA (29%) and KMT2D (22%). No genomic alteration correlated with response to platinum-containing treatment. Although there were few cases, patients with human papillomavirus-negative anal SCC did not appear to benefit from FOLFCIS, and all harbored distinct genomic profiles with TP53, TERT promoter, and CDKN2A mutations.. FOLFCIS appears effective and safe as first-line chemotherapy in patients with advanced anal SCC and represents an alternative treatment option for these patients.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Biomarkers, Tumor; Carcinoma, Squamous Cell; Female; Fluorouracil; Follow-Up Studies; Genomics; High-Throughput Nucleotide Sequencing; Humans; Leucovorin; Lymphatic Metastasis; Male; Middle Aged; Neoplasm Invasiveness; Neoplasm Recurrence, Local; Oxaliplatin; Prognosis; Retrospective Studies; Survival Rate

Anal canal cancer occasionally accompanies extramammary Paget disease. Although most of them are squamous cell carcinoma, anal canal adenocarcinoma with neuroendocrine features accompanying secondary extramammary Paget disease has never been reported.. Here, we report a 76-year-old man presented with pruritus in the perianal area. Investigation revealed a fist-sized perianal erythema, diffuse liver tumors, and right inguinal lymph node swelling. Pathological examination of biopsies from the erythema suggested secondary extramammary Paget disease with positive cytokeratin-7 and -20 expressions and negative GCDFP-15 expression. The anal canal tumor was confirmed by digital examination and endoscopy. Biopsies from the anal canal tumor, swollen lymph node, and Paget lesion all showed poorly differentiated adenocarcinoma with neuroendocrine features expressing synaptophysin and chromogranin A. Serum CEA and NSE levels were high, 809.4 ng/ml and 85.8 ng/ml, respectively. After chemotherapy with modified FOLFOX6 for 2 months, the Paget lesion disappeared, and the primary anal canal tumor and liver metastases shrunk remarkably. Serum CEA and NSE levels decreased promptly to within normal ranges.. This is a clinically significant case, as it reveals novel pathological features about anal canal cancer with secondary Paget disease and successfully treated with modified FOLFOX6. Careful pathological investigation and appropriate treatment choice are needed for this rare cancer.

Topics: Adenocarcinoma; Aged; Anal Canal; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carcinoma, Neuroendocrine; Fluorouracil; Humans; Leucovorin; Male; Organoplatinum Compounds; Paget Disease, Extramammary; Treatment Outcome

Locally advanced anal cancer patients, especially with T4 disease and fistula, have a dismal prognosis. Neo-adjuvant intra-arterial chemotherapy before standard chemoradiation has been shown to be promising in this setting.. We are reporting results from a larger patient population.. From 2005 to 2015, 25 consecutive patients with locally advanced anal cancer, 18 of them fistulised, received intra-arterial chemotherapy.. Twenty-two of 25 patients (88%) had T4N0-3 disease and 3 (12%) T3N3. An objective tumour response was observed in 24 of 25 patients (96%): 24 partial responses and 1 with stable disease. Fistulas' complete closure was observed in 15 of 18 patients (83.3%). Following intra-arterial chemotherapy, 23 patients underwent chemoradiation. Twenty-one of 25 patients (84%) had a complete remission 6 months after treatment completion. Amongst 22 patients followed for 3 or more years, 18 of them (81%) are colostomy free at 3 years. Five-year overall survival is 75%. Most frequent grade 3-4 toxicity of IAC was neutropenia (25%).. Neo-adjuvant intra-arterial chemotherapy combined to chemoradiation resulted in a high rate of fistulas closure and long-term control of locally advanced anal cancer. This interesting approach in the treatment of fistulised anal cancer, needs a prospective study before being considered a new standard strategy.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Bleomycin; Chemoradiotherapy; Chemotherapy, Adjuvant; Cisplatin; Colostomy; Disease-Free Survival; Female; Fluorouracil; Humans; Infusions, Intra-Arterial; Leucovorin; Male; Middle Aged; Mitomycin; Neoadjuvant Therapy; Neutropenia; Organoplatinum Compounds; Oxaliplatin; Radiotherapy, Intensity-Modulated; Rectal Fistula; Remission Induction; Retrospective Studies; Survival Rate

Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carcinoma, Squamous Cell; Cecal Neoplasms; Chemotherapy, Adjuvant; Colectomy; Fluorouracil; Humans; Laparoscopy; Leucovorin; Male; Neoplasm Staging; Organoplatinum Compounds

Patients with neuroendocrine carcinomas (NECs) grade 3 have a poor prognosis. Etoposide-platinum combination is the standard chemotherapy but the role of a second-line therapy remains unknown. Irinotecan alone or in combination has shown some efficacy in patients treated for small cell lung cancer which had pathological similarities with neuroendocine tumors. The aim of this study is to determine safety and efficacy of the FOLFIRI regimen in patients with NECs grade 3 after failure of etoposide-platinum combination. This study was retrospective, including patients with NECs grade 3 and treated with the FOLFIRI regimen after progression or toxicity of etoposide-platinum combination in first-line. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥3 and/or serum alkaline phosphatase ≥5×upper limit of normal value (ULN) and/or bilirubin ≥1.5×ULN were excluded. Among 39 patients who failed etoposide-platinum combination, 19 (49%; 12 women, median age 53 (29-78) years) received the FOLFIRI regimen with a median number of 6 (1-16) courses. Six patients (31%) had at least one episode of grades 3-4 toxicity (neutropenia, n=3; diarrhea, n=3) without toxic death. Six patients (31%) had objective response, 6 (31%) stable disease, and 7 (38%) tumor progression. Median progression-free survival under FOLFIRI was 4 months. Overall survival was 18 vs 6.8 months in noneligible patients. FOLFIRI regimen is a safe and potentially efficient chemotherapy given as second-line in patients with NECs grade 3 who remain in good condition and with correct liver tests after failure of etoposide-platinum combination. These results should be confirmed in a future prospective study.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Camptothecin; Carcinoma, Neuroendocrine; Disease-Free Survival; Etoposide; Female; Fluorouracil; Humans; Leucovorin; Liver Neoplasms; Male; Middle Aged; Neoplasm Grading; Pancreatic Neoplasms; Pelvic Neoplasms; Platinum; Treatment Outcome

A 66-year-old man was referred to our hospital because of a two-week history off ever and low back pain. There was a hard anal mass on rectal examination. Colonoscopy and computed tomography showed anal adenocarcinoma, multiple metastases to lymph nodes and bones. Blood test showed severe disseminated intravascular coagulation (DIC). Microscopic examination of the bone marrow aspirate revealed disseminated carcinomatosis of the bone marrow. Systemic chemotherapy (mFOLFOX6) was started, then remission of DIC and shrinkage of the tumor were observed. Although the patient had cerebral infarction during the first course of chemotherapy, he received nine courses of treatment. He died six months later because of cerebellar hemorrhage.

Topics: Adenocarcinoma; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Bone Marrow Neoplasms; Carcinoma; Disseminated Intravascular Coagulation; Fluorouracil; Humans; Leucovorin; Male; Organoplatinum Compounds

We describe our experience with a patient who had unresectable anal signet-ring cell carcinoma with extensive metastases to the lymph nodes, lungs, and bones. The patient was treated with bevacizumab (Bev)+mFOLFOX6 and achieved complete response (CR). He was a man in his fifties, who visited a local doctor with the chief complaints of swelling in the axillary and inguinal regions. Signet-ring cell carcinoma was diagnosed by examination of a biopsy specimen from the inguinal lymph nodes. A search for the primary tumor was performed, and anal canal carcinoma with pagetoid spread was detected in the perianal region. Positron emission tomography-computed tomography (PET-CT) showed an accumulation in lymph nodes throughout the body, as well as in the lungs and the bones. Bev+mFOLFOX6 therapy was initiated. After completion of 4 courses, the lymph nodes were no longer palpable. PET-CT scanning showed no accumulation. During the 8th course, tumor markers decreased to the normal range, and CR was diagnosed. When 13 courses had been completed, the patient experienced grade 3 numbness of the hands and feet, so his treatment was changed to Bev+FOLFIRI therapy. In conclusion, Bev+mFOLFOX6 therapy achieved 6 months of CR in our patient who had anal signet-ring cell carcinoma with systemic metastases, which seemed likely to have a very poor prognosis.

Topics: Anal Canal; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Bevacizumab; Carcinoma, Signet Ring Cell; Fluorouracil; Humans; Leucovorin; Lymphatic Metastasis; Male; Middle Aged; Organoplatinum Compounds; Treatment Outcome

We present a male patient with a perianal fistula of 30 years' duration that had been treated on several occasions. The patient presented with mucoid anal adenocarcinoma. He was treated with preoperative neoadjuvant chemotherapy (5-FU and leucovorin) and external radiation therapy plus laparoscopy-assisted abdominoperineal amputation. Mucoid adenocarcinoma on chronic perianal fistula is an infrequent process. Late diagnosis is associated with a poor prognosis.

Topics: Adenocarcinoma, Mucinous; Antimetabolites, Antineoplastic; Anus Neoplasms; Chemotherapy, Adjuvant; Chronic Disease; Combined Modality Therapy; Digestive System Surgical Procedures; Fluorouracil; Humans; Laparoscopy; Leucovorin; Male; Middle Aged; Perineum; Radiotherapy, Adjuvant; Rectal Fistula

The authors report their 12 years of experience of intra arterial chemotherapy in pelvic recurrences and inoperable advanced stages of uterine carcinoma, rectal cancer and anal cancer. In squamous cell cancers the drug associations were mitomycin C, bleomycin, fluorouracil and folinic acid and cisplatin. In adenocarcinoma the same protocol contained no bleomycin. Drugs were infused for a 48 hours period in continuous infusion. The dosages were the same than in the intravenous regimens. Twenty patients with pelvic recurrences were included in this retrospective study: six were uterine cancers, fourteen were colo rectal cancers and two had advanced stage uterine cancer. Pain decreased in 10/14 patients with ano-rectal cancer pre sacral recurrence. Partial response was observed in 12 patients. Complete secondary surgical resection was possible in 4/14 rectal cancers and 6/6 uterine cancer recurrences. Chemotherapy induced a pathological complete response in 4/6 uterine cervix carcinoma recurrences. These observations led to perform pelvic intra arterial chemotherapy as first line treatment of locally-advanced inoperable pelvic tumors: 11 uterine cancers and five ano-rectal cancers. The objective were: tumor reduction before radiotherapy or surgery, tumor sterilization, decrease tumor volume for better radiation dosimetry, increase the chance of organ-preservation. The observation of tumor reduction in this small number of patients does not allow to draw definite conclusions. However the introduction of intra arterial pelvic chemotherapy as first line treatment of inoperable pelvic cancer warrants further studies.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Bleomycin; Cisplatin; Drug Administration Schedule; Female; Fluorouracil; Humans; Infusions, Intra-Arterial; Leucovorin; Middle Aged; Mitomycin; Neoplasm Recurrence, Local; Rectal Neoplasms; Uterine Neoplasms

Despite great efforts chemotherapeutic results of metastatic colorectal cancer are still unsatisfactory. In general, single agent treatment with 5-fluorouracil is the standard. The combination of 5-fluorouracil and folinic acid, however, shows favorable preliminary results which can be expected to lead to a small progress in this area. During the last several years the treatment strategy of squamous cell cancer of the anus has changed profoundly. In most patients radical surgery with colostomy has become unnecessary. With combined simultaneous chemotherapy and radiotherapy about 80% of all patients can achieve long term disease free survival.

Topics: Algorithms; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Colonic Neoplasms; Combined Modality Therapy; Fluorouracil; Humans; Leucovorin; Rectal Neoplasms

Thirty patients with epidermoid carcinoma of the anus, ranging in age from 40 to 89 years, were treated with combined chemotherapy (CT) and radiation therapy (RT) in lieu of abdominoperineal resection. Two courses of 5-FU (1000 mg/m2/day X four days) by continuous infusion and mitomycin-C (10-15 mg/m2 IV bolus on day 1 of each course) were given 3 to 4 weeks apart simultaneously, with whole pelvis RT to 4140 to 4500 cGy. Twenty-one of 28 patients had T3-T4 primaries and ten had positive nodes (N1). Two of the 30 patients were treated for local recurrence following surgical excision and one was treated immediately after local excision. Twenty-six of the 30 patients attained biopsy-confirmed complete remission. Four of the 30 patients demonstrated residual disease at completion of therapy but all subsequently achieved complete remission with additional nonsurgical treatment. One patient, initially treated for local recurrence following excision failed locally at four years and was salvaged with chemotherapy followed by abdominoperineal resection. No patient has experienced distant failure. Twenty-seven of 30 patients were alive and disease free after 9 to 76 months of follow-up and three died, disease-free, of unrelated causes. Acute toxicities were mild and did not necessitate interruption of treatment. A brisk perineal reaction and diarrhea were noted in all patients. Late complications were unusual. All patients were treated in a community-based, private practice setting. The authors conclude that combined CT-RT, as employed herein, represents a first-line curative treatment for the majority of patients with epidermoid anal carcinoma. For patients who demonstrate residual disease following this therapy, salvage regimens such as 5-FU infusion and cisplatin, or sequential MTX-5-FU-Leucovorin with additional synchronous RT should be employed before resorting to radical surgery.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carcinoma, Squamous Cell; Combined Modality Therapy; Female; Fluorouracil; Follow-Up Studies; Humans; Leucovorin; Male; Middle Aged; Mitomycins; Neoplasm Recurrence, Local; Radiotherapy, High-Energy

Fifteen patients with advanced squamous cell carcinoma of the anal canal were treated with a combination of bleomycin, vincristine, and high-dose methotrexate (BOM) with leucovorin rescue. Three out of twelve patients with measurable disease had objective responses of 1, 2, and 5 months. Five of the fifteen patients had severe or life-threatening complications as a result of this treatment regimen. The narrow therapeutic index of the BOM therapy makes it a less than ideal drug combination for the treatment of advanced squamous cell carcinoma of the anal canal.

Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Bleomycin; Carcinoma, Squamous Cell; Drug Evaluation; Female; Follow-Up Studies; Humans; Leucovorin; Male; Methotrexate; Middle Aged; Neoplasm Metastasis; Vincristine