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Radioimmunotherapy of Small Cell Lung Carcinoma with The Vol. 5, 3259s-3267s, October 1999 (Suppl.) Clinical Cancer Research 3259s Radioimmunotherapy of Small Cell Lung Carcinoma with the Two- Step Method Using a Bispecific Anti-Carcinoembryonic Antigen/ Anti-Diethylenetriaminepentaacetic Acid (DTPA) Antibody and Iodine-131 Di-DTPA Hapten: Results of a Phase I/II Trial 1 Jean-Philippe Vuillez, 2 Fran~oise Kraeber-Bod~r~, mated tumor dose was 2.6-32.2 cGy/mCi. Among the 12 pa- Denis Moro, Manuel Bardi~s, tients evaluated to date, we have observed 9 progressions, 2 partial responses (one almost complete for 3 months), and 1 Jean-Yves Douillard, Emmanuel Gautherot, stabilization of more than 24 months. Efficiency and toxicity Eric Rouvier, Jacques Barbet, Frederic Garban, were dose-related. The maximal tolerable dose without hema- Philippe Moreau, and Jean-Francois Chatal tological rescue was 150 mCi. These preliminary results are Nuclear Medicine Department [J. P. V.], Pneumology Department encouraging, and dose escalation is currently continuing to [D. M.], and Hematology Department [F. G.], University Hospital, reach 300 mCi. RIT should prove to be an interesting thera- 38000 Grenoble; Nuclear Medicine Department IF. K-B., M. B., peutic method for SCLC, although repeated injections and J-F. C.], Oncology Department [J-Y. D.], and Hematology Department [P. M.], Cancer Center and University Hospital, 4400 Nantes; and hematological rescue will probably be required, as well as Immunotech Co., 13276 Marseille [E. G., E. R., J. B.], France combination with other treatment modalities. Introduction Abstract SCLC 3 represents 15-20% of all bronchogenic carcinoma As small cell lung carcinoma (SCLC) is frequently a diagnosed in France (1) and the United States (2). Over the past widespread disease at diagnosis, highly radiosensitive and 15 years, multimodality treatment, including multiagent chemo- often only partially responsive to chemotherapy, radioim- therapy, has led to an improvement in survival, but the efficacy munotherapy (RIT) would appear to be a promising tech- of SCLC treatment remains limited despite high response rates nique for treatment. We report the preliminary results of a to chemotherapy and radiotherapy. The use of combined chem- Phase I/II trial of RIT in SCLC using a two-step method and otherapy and thoracic radiation therapy for limited SCLC en- a myeloablative protocol with circulating stem cells trans- hances local control and improves survival (3); prophylactic plantation. Fourteen patients with proved SCLC relapse cranial irradiation reduces the frequency of clinically significant after chemotherapy were treated with RIT. They were first brain metastases and should be proposed to patients achieving a injected i.v. with a bispecific (anti-carcinoembryonic anti- complete response (4), whereas surgery may benefit a small gen/anti-diethylenetriaminepentaacetic acid) monoclonal number of patients with stage 1 tumor (5). However, 2-year antibody (20-80 mg in 100 ml of saline solution) and then survival is usually less than 25%, even in limited disease, and 4 days later with di-(In-diethylenetriaminepentaacetic acid)- fewer than 10% of patients are alive and tree of disease at 5 tyrosyl-lysine hapten labeled with 1.48-6.66 GBq (40-180 years (6-8). mCi) of 1-131 and diluted in 100 ml of saline solution. In RIT is an internal radiotherapy approach in which radio- patients receiving 150 mCi or more, circulating stem cells were nuclide-labeled monoclonal antibodies recognizing tumor-asso- harvested before treatment and reinfused 10-15 days later. ciated antigens are administered systemically for selective tar- Treatment response was evaluated by CT and biochemical geting of radioactivity to tumor cells. Very encouraging results data during the month before and 1, 3, 6, and 12 months after have already been obtained in NHML with or without myeloa- treatment. All patients received the scheduled dose without blation with iodine-13 I-labeled anti-CD20 monoclonal antibod- immediate adverse reactions to bispecific antibody or 1-131 ies (9-12). hapten. Toxicity was mainly hematological, with two cases of However, some well-known limitations of RIT are mostly grade 2 leukopenia and three cases of grade 3 or 4 thrombope- problematic for solid tumor. In particular, nonspecific activity in nia. Body scanning 8 days after injection of the radiolabeled normal tissues is usually too high compared to tumor uptake, hapten generally showed good uptake at the tumor sites. Esti- providing an inadequate tumor:nontumor ratio that limits the rate of injected activity (13, 14). The AES has been proposed to increase the tumor:nontumor ratios. AES consists in a two-step 1 Presented at the "Seventh Conference on Radioimmunodetection and Radioimmunotherapy of Cancer," October 15-17, 1998, Princeton, NJ. Supported by a grant from the "Program Hospitatier de Recherche 3 The abbreviations used are: SCLC, small cell lung carcinoma; RIT, Clinique" 1996 conducted by the French Ministry of Health. radioimmunotherapy; AES, affinity enhancement system; Bs, bispecific; 2 To whom requests for reprints should be addressed, at Laboratoire Ab, antibody; MAb, monoclonal Ab; HAMA, human antimouse anti- d'Etude de Radiopharmaceutiques Unite Propre de Recherche de bodies; CEA, carcinoembryonic antigen; BMT, bone marrow transplan- l'Enseignement Superieur Associ6. Centre National de la Recherche tation; NHML, non-Hodgkin malignant lymphoma; DTPA, diethylene- Scientifique 5077, Facult6 de M6decine, 38700 La Tronche, France. triaminepentaacetic acid; CT, computed tomography. Downloaded from clincancerres.aacrjournals.org on September 24, 2021. © 1999 American Association for Cancer Research. 3260s Two-Step Radioimmunotherapy for SCLC Table 1 Eligibility of patients Inclusion criteria Exclusion criteria Histologically confirmed diagnosis of SCLC Known intercurrent cancer CEA expression by primary tumor ~>40% of tumor cells Psychiatric disorders Documented known recurrence(s) Previous injected murine monoclonal antibody with positive HAMA No alternative treatment External radiotherapy and chemotherapy within the last month Bone scan within the last 3 months Unstable condition not allowing isolation therapy Serum bilirubin and serum creatinine level < 1.5• normal value Pregnancy or breast-feeding Leukocyte count >4000/mm ~ No informed consent Platelet count > 100,000/mm 3 Age -> 18 years and --<75 years Karnofsky index >60% Life expectancy >9 weeks Signed informed consent form method using a BsAb and a bivalent radiolabeled hapten (15, txSv at 1 m. To protect the thyroid gland from inappropriate 16). Dosimetric studies in patients have confirmed the possible irradiation, the patient received 30 drops of saturated solution of therapeutic benefit of this method (17). potassium iodine p.o. three times daily, beginning 3 days before The present Phase I/II dose escalation trial was undertaken injection of 131I -hapten and then for 14 days after therapy. to evaluate the feasibility and toxicity of the method. Response Toxicity Monitoring. Toxicity was assessed from clini- to treatment was evaluated as a secondary goal of the study. cal and biological data, i.e., blood cell count, liver enzyme level (aspartate aminotransferase, alanine aminotransferase, y glu- Patients and Methods tamyl transpeptidase, alkaline phosphatase, and lactate dehydro- Patients. Eligible patients were adults with histologically genase), blood biochemistry (urea, creatinine, glucose, total proved SCLC expressing the CEA antigen (at least 40% of bilirubin, total proteins, and albumin), and urine parameters tumor cells expressing CEA on a biopsy specimen), who had (protein, WBCs, and RBCs). failed at least on one prior chemotherapy regimen and had Hematological Rescue. During the first course of the assessable and measurable disease. Detailed patient selection protocol, it appeared that hematological toxicity was problem- criteria are indicated in Table 1. atic for injected activities above 5.55 GBq (150 mCi). Thus, the Reagents. A Bs anti-CEA/anti-DTPA-indium Ab protocol was modified, with the approval of the local ethics (BsMAb anti-CEA/anti-DTPA-In) designated F6-734 was ob- committee, to perform autologous BMT with peripheral stem tained by coupling an equimolar quantity of a Fab' fragment of cells. Stem cells obtained by cytapheresis after stimulation by anti-CEA MAb F6 (murine IgG1 K, specific for human CEA) to granulocyte macrophage colony-stimulating factor (10 txg/kg of a Fab fragment of anti-DTPA-In MAb 734 (murine IgG1M body weight for 5 days) were systematically harvested before specific for DTPA-In complexes) previously activated by o- RIT for doses of 150 mCi or more. RIT was then performed if phenylenedimaleimide. more than 1.5 • 106 stem cells (CD34+)/kg were obtained; if The bivalent DTPA hapten N-oL-DTPA-tyrosyl-n-e-DTPA- not, the injected activity was reduced to 100 mCi. When BMT lysine (di-DTPA) was obtained by reaction of DTPA dianhy- was scheduled, stem cells were reinjected as soon as blood dride with tyrosyl-lysine diacetate (18). 131I -bivalent hapten activity became lower than 1 bLCi/ml. (13JI -di-DTPA-In) was provided by Cis Bio-International Treatment Effectiveness. Response to treatment was (Saclay, France). Before labeling, DTPA bivalent hapten was evaluated by clinical data, morphological imaging (CT, ultra- saturated with indium in an indium chloride solution because sound, and sometimes magnetic resonance imaging), and bio- MAb 734 only recognizes the DTPA-In complex. logical data (CEA and neuron-specific enolase serum
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