reported a phase I-II study of radiation plus continuous infusion of carboplatin in 12 patients with stages IIB and IIIB cervical cancer, using 12 mg/m2/day for a total dose of 504 mg/m2 in 42 days, equivalent to 250 mg/m2 every 21 days for two courses. Careers, Unable to load your collection due to an error. Rodriguez M, Sevin BU, Perras J, Nguyen HN, Pham C, Steren AJ, Koechli OR, Averette HE: Paclitaxel: a radiation sensitizer of human cervical cancer cells. Muderspach LI, Chafe WE, Suggs CL, 3rd, et al. Regarding toxicity, five patients (26%) had grade 3 small bowel toxicity (three at 40 mg/m2 and two at 60 mg/m2); another patient at 40 mg/m2 presented grade 3 bladder toxicity, while another had grade 4 mucositis [84]. Gynecol Oncol 2005, 96: 194-197. Capecitabine is an orally available fuoropyrimidine carbamate that generates the active drug 5-Fura selectively in tumors by three enzymes located in liver and in tumors; the final step is the conversion of the intermediate metabolite 5'-dFUrd into 5-FUra by dThdPase (thymidine phosphorylase) in tumors [105]. We acknowledge all our team members who are involved in patient care and management of the recruited patients. The radiation plan included external-beam radiation therapy with intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy and image-guided brachytherapy with 3-dimensional treatment planning. 10.1023/A:1008379922120, Rao GG, Rogers P, Drake RD, Nguyen P, Coleman RL: Phase I clinical trial of weekly paclitaxel, weekly carboplatin, and concurrent radiotherapy for primary cervical cancer. Similar findings were reported on lack of sensitation by paclitaxel utilizing C33A and MS751 cervical cancer cell lines under conventional fraction-size doses or radiation [82]. On behalf of the Gynecologic Oncology Group, we performed a randomized trial of radiotherapy in combination with three concurrent chemotherapy regimens cisplatin alone; cisplatin,. This was owing to acute toxicities, namely leucopenia (0.73.8 109/L), neutropenia (0.51.5 109/L), and thrombocytopenia (3398 109/L). Bonomi P, Blessing JA, Stehman FB, et al. Leucopenia was the most common and severe toxicity observed compared to neutropenia and thrombocytopenia in both arms. Paclitaxel is a potent microtubule-stabilizing agent that selectively blocks cells in cell-cycle G2 and M phases and is cytotoxic in a time concentration-dependent manner. While doxorubicin has been evaluated as a radiosensitizer in several systems including cervical cancer cell lines, demonstrating its synergy with radiation [63], there is a scarcity of studies on this with epirubicin. Intracavitary brachytherapy was delivered using modified Fletcher-Suit manual after-loading low dose rate (Cs137) applicators to a total dose of 30 Gy to point A. ICRU 38 guidelines were followed in the planning and treatment of brachytherapy. Statistical analysis was performed using the SPSS inc. Int J Radiat Oncol Biol Phys 1999, 45: 991-998. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Clinically apparent disease at 6 weeks after the completion of treatment was classified as having 0 months of the disease-free interval. Chen AY, Choy H, Rothenberg ML: DNA topoisomerase I-targeting drugs as radiation sensitizers. Zhu J, Ji S, Hu Q, et al. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. At a median follow-up time of 15 months, there were no differences in either local control or survival; however, acute grade 23 toxicity frequency was significantly higher as observed in patients receiving hyperthermia (18 vs. 4%). Internal radiation is then given using high-dose brachytherapy, in which high doses of radioactive material are applied through a specialized applicator directly to the tumor. The authors conclude that topotecan is safe at 1 mg/m2. The authors suggest that ureteral obstruction causing any degree of renal insufficiency should not be a contraindication for receiving chemoradiation to attempt a cure and that in this setting in which cisplatin is contraindicated; gemcitabine use should be considered [97]. Federal government websites often end in .gov or .mil. 10.1016/j.ygyno.2004.09.009, Pauwels B, Korst AE, Lardon F, Vermorken JB: Combined modality therapy of gemcitabine and radiation. The authors administered paclitaxel weekly at 40 or 60 mg/m2 during the entire external radiotherapy course. Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY: A randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stages IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes. The haematological and biochemical acute toxicities were evaluated twice weekly using the CTCAE version 3.0. Remarkably, three patients (23%) presented late Radiation Therapy Oncology Group/Eastern Cooperative Oncology Group (RTOG/ECOG) grade 3 toxicity bladder or vaginal mucosa at 6, 9, and 15 months. New Engl J Med 1999, 340: 1154-1161. Although the haematological toxicities, like leucopenia and neutropenia, observed in the study were severe, the treatment was well tolerated in the remaining patients by temporarily suspending therapy and supporting transfusions when necessary, the high incidence of the haematological reactions might be due to the difference in the median dose compared to our study. Tanaka T, Yukawa K, Umesaki N: Combination effects of irradiation and irinotecan on cervical squamous cell carcinoma cells in vitro. Afterwards, a meta-analysis based on 19 trials (17 published and two unpublished) including 4,580 patients corroborated these findings, confirming that chemoradiation offers an absolute survival benefit of 12% at 5 years [14]. While there was no difference in progression-free survival between cisplatin alone and the FU-cisplatin regimen, a significant difference in adverse events for the three-drug regimen was demonstrated [13]. The most common acute toxicity observed was grade III leucopoenia. 10.1006/gyno.2000.6109, Serkies K, Jassem J: Concurrent weekly cisplatin and radiotherapy in routine management of cervical cancer: a report on patient compliance and acute toxicity. The median overall treatment time was 46 and 47 days in arm A and arm B, respectively. Comparison of toxicities in weekly and three weekly arms, UGI upper gastrointestinal; LGI lower gastrointestinal; Low grade 1 and 2; High grade 3 and 4; N number of patients. Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix: a Gynecologic Oncology Group study. 10.1006/gyno.1995.1119, Erlich E, McCall AR, Potkul RK, Walter S, Vaughan A: Paclitaxel is only a weak radiosensitizer of human cervical carcinoma cell lines. On the contrary, our study showed significantly higher upper and lower gastro-intestinal toxicity and statistically insignificant haematological toxicity. Often, a low dose of the chemo drug called cisplatin is used. Radiother Oncol 2004, 70: 295-299. In the present work, we present preclinical information on known and newer cytotoxic agents as radiosensitizers on cervical cancer models, as well as the clinical information emanating from early phase trials that incorporate them to the cervical cancer management. The cytotoxic dose of 100 mg/m2 in the tri-weekly arm in our study was considered owing to the higher peak concentration of cisplatin possibly more critical in enhancing the efficacy of chemoradiation than weekly cisplatin. We conducted a trial to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed . Thus, cisplatin-based chemoradiation was largely accepted as the standard of care for patients with cervical cancer whose treatment required radiation, except for patients with co-morbidities who are radiated for stage IB1 or less. Gaffney DK, Erickson-Wittmann BA, Jhingran A, et al. 10.1200/JCO.2004.00.0497, Abu-Rustum NR, Lee S, Correa A, Massad LS: Compliance with and acute hematologic toxic effects of chemoradiation in indigent women with cervical cancer. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. reported in their observations the toxicity of a series of 177 patients who also received chemotherapy that consisted of infusional 5-fluorouracil during the first and last weeks of the radiotherapy's external beam component, combined with bolus mitomycin C (64 patients) or without mitomycin C (29 patients). External beam radiation was delivered to the entire pelvic region in 23 fractions over 5 weeks for a total dose of 46 Gy. In 26 evaluable patients, vinorelbine at 25 mg/m2/week was well- tolerated the primary toxicity hematological. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. In case of uncontrolled symptoms, levosulpiride (a class of benzamides) was added. the contents by NLM or the National Institutes of Health. Results show that addition of 5-FU did not improve pelvic control or overall survival; nonetheless, the study was underpowered due to early closing. Randomized phase 3 trial comparing 2 cisplatin dose schedules in 326 patients with locally advanced squamous cell cervical carcinoma: long-term follow-up. Zarba JJ, Jaremtchuk AV, Gonzalez Jazey P, Keropian M, Castagnino R, Mina C, Arroyo G: A phase I-II study of weekly cisplatin and gemcitabine with concurrent radiotherapy in locally advanced cervical carcinoma. In the GOG 120, weekly cisplatin was directly compared with FU/cisplatin/hydroxyurea in combination with radiation. 10.1016/j.ijrobp.2004.04.042, Cetina L, Rivera L, Hinojosa J, Poitevin A, Uribe J, Lpez-Graniel C, Cant D, Candelaria M, de la Garza J, Dueas-Gonzlez A: Routine management of locally advanced cervical cancer with concurrent radiation and cisplatin. Results were reported as encouraging, with good control local rates and tolerable side effects [5153]. Stehman FB, Bundy BN, Thomas G, Keys HM, d'Ablaing G 3rd, Fowler WC Jr, Mortel R, Creasman WT: Hydroxyurea versus misonidazole with radiation in cervical carcinoma: long-term follow-up of a Gynecologic Oncology Group trial. The hydroxyurea arm resulted in a higher complete response rate (68 vs. 49%), longer median progression-free and median survival (13.6 vs. 7.6 m) and (19.5 vs. 10.7 m), respectively. Int J Cancer 2000, 90: 206-223.Publisher Full Text10.1002/1097-0215(20000820)90:4206::AID-IJC43.0.CO;2-O, Christie DR, Bull CA, Gebski V, Langlands AO: Concurrent 5-fluorouracil, mitomycin C and irradiation in locally advanced cervix cancer. In this study, 13 patients received a twice-daily dose of capecitabine at either 300 or 450 mg/m2 plus a fixed dose of weekly cisplatin at 40 mg/m2 during external pelvic radiation. At this level, grade 3 or 4 hematological toxicities were maintained <10%. Nineteen patients were evaluable for response; a complete response was obtained in eight of the 13 new cases (62%) and in four of the six recurrences (66%), for a total complete response rate of 63%. Int J Radiat Oncol Biol Phys 2003, 56: 1284-1287. 4-Epidoxorubicin, an analog of anthracycline, is known to have activity against cervical cancer when tested as single agent in patients with recurrent or advanced disease [61, 62]. Other chemo drugs can be used as well. Vinorelbine, a semi-synthetic vinca alkaloid, is a potent inhibitor of mitotic microtubule polymerization. The upper gastrointestinal toxicity in the form of nausea and vomiting was statistically higher in the tri-weekly arm (4.9% vs. 0.9%, p = 0.03) and was managed using 5-hydroxytryptamine3 blockers. Gynecol Oncol 1999, 73: 177-183. Despite the fact that all patients achieved complete response, the tested schedule produced unacceptable toxicity, which led the authors to conclude that gemcitabine-administered prior to cisplatin with radiation for cervical cancer-will likely require cisplatin dose reduction [103]. New Engl J Med 2001, 345: 725-730. These studies with the combination of cisplatin and gemcitabine plus radiation were not intended, however, to establish the recommended dose for the scheme. In this line, gemcitabine is the newer cytotoxic agent with the most extensive evaluation. Based upon the biologic rationale and in view of the recent advances in heating and thermometry techniques, radiotherapy in combination with hyperthermia has been tested in cervical cancer. Descriptive statistics were used to express data. It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer. bone marrow suppression. Cancer Res 1990, 50: 7483-7489. At a median follow-up of 11 months (range, 614 months), all patients are alive, one with pelvic and another with systemic disease. Introduction. 10.1016/S0305-7372(03)00068-9, PubMed 10.1016/j.ctrv.2004.01.002. Thus, current data suggest that irinotecan is not a promising agent for use in chemoradiation protocols for cervix carcinoma, but further preclinical studies on the issue are warranted. Whether this schedule of gemcitabine first is or is not more effective will require additional testing. Cancer Treat Rev 1985, 12: 111-124. CAS 10.1006/gyno.1998.5204, Hallum AV 3rd, Alberts DS, Lippman SM, Inclan L, Shamdas GJ, Childers JM, Surwit EA, Modiano M, Hatch KD: Phase II study of 13-cis-retinoic acid plus interferon-alpha 2a in heavily pretreated squamous carcinoma of the cervix. This drug is given into a vein (IV) before the radiation appointment. Int J Hyperthermia 2001, 17: 97-105. Likewise, in another lung cancer cell line Fukuoka et al. This dose level is within the range reported for capecitabine and pelvic radiotherapy for patients with rectal cancer, which varies from 1,6001,800 mg/m2 [110, 111]. Surprisingly, three of the six patients receiving gemcitabine at 100 mg/m2 presented dose-limiting toxicity that consisted of severe fatigue, lymphopenia, diarrhea, and tinnitus; therefore, de-escalation to 50 mg/m2 was decided upon. Detailed Description: OBJECTIVES: Primary In another report, 112 patients with cervical cancer received five planned courses of cisplatin at 40 mg/m2 during external radiation; 62 patients (55%) did not undergo the five planned cycles of cisplatin due to treatment toxicity (31%) or non-compliance due to delayed first-cycle administration or omission of a cycle for reasons other than toxicity (21%) [26]. J Clin Oncol 2000, 18: 1606-1613. 10.1097/00000421-199712000-00017, Muderspach LI, Curtin JP, Roman LD, Gebhardt JA, Klement V, Qian D, Morrow CP, Felix JC, Formenti SC, Muggia FM: Carboplatin as a radiation sensitizer in locally advanced cervical cancer: a pilot study. Wong LC, Choy DT, Ngan HY, Sham JS, Ma HH: 4-epidoxorubicin in recurrent cervical cancer. The cisplatin regimen used in their study was almost similar, except that the three-weekly doses were 100 mg/m2 in our study. Patients were randomly assigned to radiotherapy alone (group 1), the same radiotherapy combined with cisplatin at a dose of 30 mg/m2 by intravenous (i.v.) Hreshchyshyn MM, Aron BS, Boronow RC, Franklin EW 3rd, Shingleton HM, Blessing JA: Hydroxyurea or placebo combined with radiation to treat stages IIIB and IV cervical cancer confined to the pelvis. Gynecol Oncol 2000, 79: 272-280. Cervical cancer is currently staged clinically according International Federation of Gynecology and Obstetrics (FIGO) guidelines. FOIA BMC Women's Health 2006, 6: 3. Cisplatin plus 5-fluorouracil (5-FU) given every 3 weeks during radiation. Camptothecin is a naturally occurring cytotoxic alkaloid that has a unique intracellular target, topoisomerase I, a nuclear enzyme that reduces supercoiled DNA torsional stress during replication, recombination, transcription, and DNA repair. PubMed Central In this line, a phase II randomized study was initiated primarily to compare rate of pathologic complete response as a surrogate marker of survival [101] between the experimental arm of cisplatin and gemcitabine using the Zarba regimen (40 mg/m2 and 125 mg/m2, respectively, vs. cisplatin alone (40 mg/m2). Department of Radiation Oncology, Kidwai Memorial Institute of Oncology, Bangalore, India. Cisplatin dosing was initiated at 6 mg/m2/day, which was incremented by 0.5 mg/m2/day. Three of the five National Cancer Institute (NCI)-sponsored studies that served for recommending chemoradiation as standard of care for all patients with locally advanced cervical cancer whose treatment require radiation used oral hydroxyurea in the control arm. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. Taken together, these results clearly position gemcitabine as one of the most promising radiosensitizer agents for cervical cancer. The patient characteristics are listed in Table 1. Conclusion: Our results show that pelvic RT combined with weekly cisplatin in cervical cancer patients is accompanied by considerable acute toxicity. Main toxicities were hematological and gastrointestinal. European Organization for Research and Treatment of Cancer Trial 22931. Address for correspondence: Dr. R Nanda, Associate Professor, Department of Radiation Oncology, Kidwai Cancer Institute, Hosur Road, Bangalore 560029, tel: +91-9341241084; e-mail: Received 2021 Aug 23; Accepted 2021 Oct 28. 10.1186/1472-6874-6-3, PubMed Central As a library, NLM provides access to scientific literature. 10.1007/PL00002351. Semin Hematol 1994, 31: 31-37. Cancer Treat Rev. The https:// ensures that you are connecting to the PURPOSE Although chemoradiation therapy (CRT) with cisplatin remains the standard treatment of patients with locally advanced cervical cancer (LACC), 40% of patients present with disease recurrence. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Hematol Oncol Clin North Am 2004, 18: 55-80. Five-year results. All together, these data suggest that paclitaxel would have a limited benefit as a radiosensitizer for cervical cancer treatment. This planned scheme proved to be toxic, because the first three patients presented grade 3 or higher hematological toxicity; hence, cisplatin was administered only once a week. Chan P, Milosevic M, Fyles A, Carson J, Pintilie M, Rauth M, Thomas G: A phase III randomized study of misonidazole plus radiation vs. radiation alone for cervix cancer. 10.1006/gyno.2000.6051. Gynecol Oncol 2005, 97: 790-795. Whitney CW, Sause W, Bundy BN, et al. Ann Oncol 2000, 11: 455-459. Patients in arm A received 40 mg/m2 of concurrent cisplatin once a week and arm B received 100 mg/m2 of concurrent cisplatin once in 3 weeks. 10.1016/j.radonc.2003.11.018, Macdonald J, Smalley S, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA: Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. PubMed 10.1006/gyno.2001.6197. These results were updated, observing 10-year overall survival for patients in the misonidazole arm of 45%, compared with 49% for the placebo arm (p = 0.89). Thus, older agents such as mitomycin C and even 5-fluorouracil have played a limited role in this malignancy. Radiation therapy and concurrent cisplatin administration in locally advanced head and neck cancer. Chemo may be used to treat cervical cancer that has spread to . Subsequent studies in pre-treated cervical cancer failed to demonstrate the antitumor activity of the combination [117, 118]. Different from the previously mentioned studies of cisplatin and gemcitabine in combination in which cisplatin was administered first, in this study the inverse order was chosen; thus, gemcitabine was followed by cisplatin. Three dose-finding studies have been performed combining either carboplatin or cisplatin with paclitaxel. Thus, the regimen of weekly cisplatin concurrent with radiation was chosen as the standard treatment approach in the GOG for locally advanced cervix cancer and was the regimen with which new combination treatments should be compared. J Clin Oncol 2005, 23: 8289-8295. Radical concurrent chemoradiation is the current standard of treatment in locally advanced cervical cancer. Overall treatment time was intended to be 4951 days from the start of pelvic irradiation. Rose PG, Ali S, Watkins E, et al. No significant difference was observed between the two arms to acute adverse effects. In a phase I trial of topotecan administered with standard external-beam radiotherapy in advanced squamous cell carcinoma of the cervix, patients were treated with a starting dose of 0.5 mg/m2 and escalated by 0.25 mg/m2 daily for 5 days on days 15 and 2226 concomitantly with radiotherapy. Finally, the authors recommend a tri-weekly over weekly cisplatin regimen for concurrent chemoradiation arm in patients with locally advanced cervical cancer given the better response of the disease. A study has demonstrated that with vinorelbine at 1 nM, the radiation-induced DNA strand breaks observed in human SCLC SBC-3 cells are not completely repaired at 24 hours suggesting that radiosensitization by vinorelbine may-at least in part-be associated with DNA repair impairment following radiation-induced DNA damage [77]. Addition of chemotherapy to radiation has improved 5-year survival by 6%. It was seen that there was a high incidence of late rectal reactions requiring intervention due to the high cumulative rectal dose. 10.1016/j.ijrobp.2004.04.057, Ma BB, Bristow RG, Kim J, Siu LL: Combined-modality treatment of solid tumors using radiotherapy and molecular targeted agents. MMC sensitivity has been shown associated with high DTD levels by some workers, but others have demonstrated discrepancies between in vitro and in vivo cytotoxicity. Anticancer Drugs 2004, 15: 761-766. The total bladder and rectal doses were restricted to a maximum of 70 Gy and 65 Gy, respectively. 10.1002/ijc.1440, CAS Research Open Access Published: 11 February 2019 3-weekly or weekly cisplatin concurrently with radiotherapy for patients with squamous cell carcinoma of the head and neck - a multicentre, retrospective analysis Seth Helfenstein, Oliver Riesterer, Urs R. Meier, Alexandros Papachristofilou, Benjamin Kasenda, Miklos Pless & Sacha I. Rothschild Few studies have compared concurrent weekly administration of cisplatin versus a cytotoxic dose administered once in 3 weeks [1518]. A Hellenic Cooperative Oncology Group study. Gynecol Oncol 1998, 69: 137-145. It is remarkable that these rates occur, despite the fact that cervical cancer is a model for early detection due to its long and relatively well-known natural history that offers an excellent opportunity for its detection before lesions become invasive [2]. Interestingly, the effect on this system was dependent on G2/M arrest induction. In their study, patients with locally advanced cervical cancer were to be treated with cisplatin at 40 mg/m2 plus escalating doses of gemcitabine beginning at 75 mg/m2 with 25-mg/m2 increments. Symonds RP, Collingwood M, Kirwan J, Humber CE, Tierney JF, Green JA, Williams C: Concomitant hydroxyurea plus radiotherapy versus radiotherapy for carcinoma of the uterine cervix: a systematic review. Gynecol Oncol 2006, 100: 70-75. (If cisplatin is not a good option, carboplatin may be used instead.) Lorvidhaya V, Chitapanarux I, Sangruchi S, Lertsanguansinchai P, Kongthanarat Y, Tangkaratt S, Visetsiri E: Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial. , the effect on this system was dependent on G2/M arrest induction CTCAE version 3.0 between the two to! Irinotecan on cervical squamous cell carcinoma cells in vitro cancer trial 22931 Q et! A semi-synthetic vinca alkaloid, is a potent microtubule-stabilizing agent that selectively blocks cells in vitro FIGO guidelines... Was almost similar, except that the three-weekly doses were 100 mg/m2 in our study showed higher! Second half of the study sponsor and investigators weekly vs. cisplatin and radiation for cervical cancer brand cialis cisplatin-based chemotherapy concurrent radiotherapy! 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